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EC number: 258-649-2 | CAS number: 53585-53-8
- Life Cycle description
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- Endpoint summary
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- Particle size distribution (Granulometry)
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- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The skin sensitising properties of Dibenzylbenzene, ar-methyl derivative was evaluated in various guideline studies.
Based on the study results it has been concluded that Dibenzylbenzene, ar-methyl derivative is not a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not mentioned
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before REACH was implemented.
- Species:
- guinea pig
- Strain:
- other: Pirbright white DHPW (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 317 - 425 g
- Housing: collective housing up to maximum of 5 animals per cage in Makrolon cages type IV
- Diet (e.g. ad libitum): Ssniff G complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 3.5
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1990-07-18 To: not mentioned - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 5%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 5 % test substance in a mixture of FCA and water (1:2) - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Concentrations used for challenge: 100 %
- No. of animals per dose:
- test group: 20 animals
control group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
Intradermal injection: The test articel was diluted with water and FCA to give a final concentration of 5%. Two animals were employed, skin reactions .
being recorded 48 h after treatment.
Dermal application: A closed patch exposure was effected by means of an occlusive bandage. Two animals were empoyed for each concentration tested (100%; 50%) and skin reactions were recorded 48 h p.a.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 mL); 2nd exposure: epicutaneous for 48 hours
- Concentration in Freunds Complete Adjuvants (FCA): 5 % test substance in a mixture of FCA and water (1:2)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 7: pretreatment with sodium lauryl sulfate (10% in petrolatum) and day 8: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene, historical control
- Positive control results:
- The last periodic use of the positive control substance (2,4 dinitrochlorobenzene) resulted in an acceptable level of response in the test animals, not tested in parallel (no further details mentioned).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found to be not sensitizing in an OECD guideline study according to Magnusson-Kligman.
- Executive summary:
The skin sensitization potential of the substance was determined in a Guinea pig maximization test with 20 treated and 20 control Guinea pigs.
A series of three intermal injections were carried out, with the test item at 5% in paraffin oil, a 1:1 mixture of Freund's Complete Adjuvant (FCA) with the test item at 10% in paraffin oil (final concentration: 5%), and a 1:2 mixture FCA in water. Control animals received the same injections but without the test item.
One week later, a topical application of the test item at 100% or paraffin oil was conducted on the skin of the treated and control animals, following a pretreatment with 10 % sodium lauryl sulfate (SLS) in petrolatum.
The challenge was conducted two weeks later using a patch loaded with 100% of the test item, applied for 24 hours.
Scoring of the cutaneous reaction was undertaken 24 and 48 hours after removal of the patch.
No cutaneous reaction was recorded in treated nor control animals 24 and 48 hours after the removal of the challenge patch. Therefore, the substance should not be classified as sensitizating to skin.- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1989-04-11 to 1989-05-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before REACH was implemented.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 312 g (mean weight of the test animals); 328 g (mean weight of the control animals)
- Housing: 1 - 5 animals in Makrolon cages type IV
- Diet (e.g. ad libitum): G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1989-04-11 To: 1989-05-05 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 20 % in corn oil; dermal treatment: 100 % (undiluted)
- Concentration in Freunds Complete Adjuvant (FCA): 20 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 % - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 20 % in corn oil; dermal treatment: 100 % (undiluted)
- Concentration in Freunds Complete Adjuvant (FCA): 20 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 % - No. of animals per dose:
- test group: 19 animals
control group: 10 animals - Details on study design:
- RANGE FINDING TESTS: no details mentioned
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; in order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area of the test and control animals was pretreated with sodium dodecyl sulphate (10 % in vaseline)
- Concentration in Freunds Complete Adjuvants (FCA): 20 % test substance in a mixture of FCA and corn oil (1:1)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: corn oil (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium dodecyl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 100 % (undiluted)
- Evaluation: 24 and 48 hours after patch removal - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the OECD guideline study according to Magnusson-Kligman the test material was found not to be sensitizing.
- Executive summary:
The skin sensitization potential of the substance was determined in a Guinea pig maximization test with groups of 20 (treated) or 10 (control) Guinea pigs.
A series of three intermal injections were carried out, with the test item at 20% in corn oil, a 1:1 mixture of Freund's Complete Adjuvant (FCA) with the test item at 20% in corn oil, and a 1:1 mixture FCA in water. Control animals received the same injections but without the test item.
One week later, a topical application of the test item at 100% or corn oil was conducted on the skin of the treated and control animals, following a pretreatment with 10 % sodium lauryl sulfate (SLS) in petrolatum
The challenge was conducted two weeks later using a patch loaded with 100% of the test item, applied for 24 hours.
Scoring of the cutaneous reaction was undertaken 24 and 48 hours after removal of the patch.
Weight loss was reported 10 to 14 days after the beginning of the experiment.
No cutaneous reaction was recorded in treated nor control animals 24 and 48 hours after the removal of the challenge patch. Therefore, the substance should not be classified as sensitizating to skin.- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1994-11-08 to 1994-12-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test was performed before REACH was implemented.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany
- Age at study initiation: young adults, no further details mentioned
- Weight at study initiation: 379 g (mean value)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-11-08 To: 1994-11-11 (preliminary study)
From: 1994-11-29 To: 1994-12-30 (main study) - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No. of animals per dose:
- test animals: 20 (main experiment), 2 (pilot study), 3 (determination of challenge concentration)
control animals: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the non-irritant concentration of the test substance on 2 animals with occlusive epicutaneous applications for 6 hours of test substance 5 %, 25 %, 50 % in maize germ oil and undiluted. Readings at 30 and 54 hours after application. In 3 additional animals the challenge concentration was determined with dermal application of test substance 5 %, 25 %, 50% in maize germ oil and undiluted.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: occlusive dermal applications for 6 hours, scoring at 30 hours after application
- Test group: receiving test substance (0.3 cm³/patch)
- Control group: receiving vehicle (0.3 cm³/patch)
- Site: left flanks
- Frequency of applications: induction on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: occlusive dermal application for 6 hours
- Test groups: receiving test substance and vehicle (0.3 cm³/patch each)
- Control group: receiving test substance and vehicle (0.3 cm³/patch each)
- Site: right flanks (front: vehicle, back: test substance)
- Concentrations: 100 %
- Evaluation (hr after challenge): 30 and 54 hours after application
OTHER: none - Challenge controls:
- same treatment as test group animals
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
- Positive control results:
- To test the responsiveness of the used guinea-pig strain to 2-Mercaptobenzothiazole 20 test and 10 control animals were used. Any reactions, especially erythema and edema were 24, 48 and 72 hours evaluated after challenge. The highest concentration for application was 50% in vaseline. No positive control substance related systemic effects or changes in body weight gains were observed. The dermal treatments of the three induction phasesshowed no dermal irritations 30 hours p.a.. The challenge application resulted in erythema and edema in 4 test animals 30 hours p.a. at the application area of the positive control substance. A fifth animal showed dermal reactions 54 hours p.a.. In toto showed 25% of the test animals positive skin reactions, therefore the test strain was jugded to be sensitive in the Buehler test.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a standard guinea pig skin sensitisation assay according to Buehler no skin sensitisation was observed.
- Executive summary:
The skin sensitization potential of the substance was determined in a Buehler test with groups of 20 (treated) or 10 (control) Guinea pigs.
In a preliminary test, a concentration of 100% of the test item did not cause skin irritation, and was thus selected for the main test.
Three inductions were conducted on Day 0, 7 and 14, then challenge was performed on Day 28 by topical application of the test item for 6 hours.
Cutaneous reactions were recorded 30 and 54 hours after the challenge.
During the experiment, no clinical signs nor impairment of the bodyweight were recorded, apart from a delayed bodyweight gain in one control animal and a slight weight loss at the end of the study in one treated animal.
No cutaneous reaction was recorded in treated nor control animals 30 and 54 hours after the challenge. Therefore, the substance should not be classified as sensitizating to skin.- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Study conducted prior to the adoption of the most recent version of this Guideline
- Deviations:
- yes
- Remarks:
- the test design was different from the recommended one: no control test was performed, 10 topical applications for induction phase were used instead of only one, the challenge application was performed on day 36 instead of days 20 to 22.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before REACH was implemented.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 300 - 400 g
- Housing: housed per group of 5 in cages measuring 540 x 360 x 315 mm
- Diet (e.g. ad libitum): 50 g of food per animal per day in the form of granules
- Water (e.g. ad libitum): softened and filtrated water ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 55 +/- 10
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
2 animals/sex were given test substance on shaved skin at 0.5 and 0.25 mL per animal.
MAIN STUDY.
A) INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: From day 1 to day 22
- Test groups: The 20 test animals were treated as follows:
. 2 intradermal injections of 0.1 mL of Freund's Complete Adjuvant (diluted to 50% in sterile isotonic saline) on days 1 and 10.
. 10 epicutaneous applications of 0.5 mL of test substance for 48 hours on days 1, 3 , 5, 8, 10, 12, 15, 17, 19 and 22.
- Control group: no
- Site: the application site is just above the injection site (immediately behind the right shoulder blade)
- Concentrations: 0.5 mL of test substance (not diluted) per animal.
B) CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 36
- Exposure period: 48 hours
- Test groups: 1 epicutaneous application of 0.5 mL of test substance per animal
- Control group: no
- Site: the application site is on the left flank of the abdomen
- Evaluation (hr after challenge): 1 and 6 hours after removal of the occlusive patch on days 38, 39 and 40. - Challenge controls:
- No
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0.5 mL/animal
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 0.5 mL/animal
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL/animal
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 4th reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL/animal
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- none
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No cutaneous reaction was observed in any of the tested animals. Therefore, the substance should not be classified as sensitizating to skin according to EC criteria for classification of dangerous substances.
- Executive summary:
The skin sensitization potential of the substance was determined in a Guinea pig maximization test.
Twenty albino Hartley guinea pigs (10 males and 10 females) were used. The induction period included 10 topical applications of dibenzyltoluene using occlusive patches and 2 intradermal injections of Freund's complete adjuvant. The test substance is applied 3 times per week (0.5 ml pure substance per animal ; 48 hours contact) on the clipped shoulders areas.
After this induction period, a 10 day-suspension of treatment is set. Then, a challenge reaction is realized by applying 0.5 ml of the pure test substance on the left flank of the abdomen, under occlusive patch for a 48 hours contact.
Macroscopic skin reactions are evaluated 1, 6, 24, and 48 hours after patch removing. Erythema and oedema are scored according to a standardized scale (0-4). Macroscopical reactions are confirmed by an histological examination.
No cutaneous reaction was elicited in any of the tested animals. Therefore, the substance should not be classified as sensitizating to the skin.
Referenceopen allclose all
RESULTS OF PILOT STUDY:
Intradermal treatment: no specific findings
Dermal application: no skin irritation
RESULTS OF PILOT STUDY:
100 % test substance (undiluted test substance as supplied) caused no dermal irritation.
RESULTS OF TEST
- Sensitization reaction: No signs of dermal irritation were found on the test animals or the control animals 24 and 48 hours after patch removal.
- Clinical signs: 10 - 14 days after the beginning of the test most of the animals (test and control group) showed weight losses and paralysis. After administration of vitamin C in the drinking water for several days before challenge the animals recovered slowly. One animal died before challenge treatment. The administration of vitamin C was carried out until the end of the test. A bacteriological examination after the end of the test showed no specific findings.
Reactions after intracutaneous application: All animals treated with FCA showed erythema and edema and clearly pronounced necrosis, clearly pronounced erythema and edema at the injection sites of the animals treated with 20 % test substance and slight erythema at the control animals.
Reactions after patch-test for 48 hours: severe dermal inflammation of injection sites of all FCA treated animals (test and control animals). The whole application area showed severe erythema and edema, partly injection sites with deep damage. After 24 hours incrustation of FCA treated injection sites.
RESULTS OF PILOT STUDY:
None of the test substance formulation did cause any skin irritations on the three animals in the preliminary test 30 and 54 hours after administration. The determination of the challenge concentration in the 4th week of the test on three untreated animals of the same age led to no signs of dermal irritation after administration of the 5, 25, 50 and 100 % test substance. On the basis of these results the undiluted test substance was specified for the induction phases and the challenge treatment in the main test.
RESULTS OF TEST
Sensitization reaction: no sensitising effects observed
Clinical signs: no systemic effects and no impairment of body weight gain due to the test substance were observed in the test and control animals
PRELIMINARY STUDY:
A slight ertythema was observed in one male at 6h after a 0.5 ml application.
MAIN STUDY:
No cutaneous reactions were observed at any examination time after removal of the dressing.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
IFREB 1981
The skin sensitization potential of the substance was determined in a Guinea pig maximization test.
Twenty albino Hartley guinea pigs (10 males and 10 females) were used. The induction period included 10 topical applications of dibenzyltoluene using occlusive patches and 2 intradermal injections of Freund's complete adjuvant. The test substance is applied 3 times per week (0.5 ml pure substance per animal ; 48 hours contact) on the clipped shoulders areas.
After this induction period, a 10 day-suspension of treatment is set. Then, a challenge reaction is realized by applying 0.5 ml of the pure test substance on the left flank of the abdomen, under occlusive patch for a 48 hours contact.
Macroscopic skin reactions are evaluated 1, 6, 24, and 48 hours after patch removing. Erythema and oedema are scored according to a standardized scale (0-4). Macroscopical reactions are confirmed by an histological examination.
No cutaneous reaction was elicited in any of the tested animals. Therefore, the substance should not be classified as sensitizating to skin.Hüls AG 1995
The skin sensitization potential of the substance was determined in a Buehler test with groups of 20 (treated) or 10 (control) Guinea pigs.
In a preliminary test, a concentration of 100% of the test item did not cause skin irritation, and was thus selected for the main test.
Three inductions were conducted on Day 0, 7 and 14, then challenge was performed on Day 28 by topical application of the test item for 6 hours.
Cutaneous reactions were recorded 30 and 54 hours after the challenge.
During the experiment, no clinical signs nor impairment of the bodyweight were recorded, apart from a delayed bodyweight gain in one control animal and a slight weight loss at the end of the study in one treated animal.
No cutaneous reaction was recorded in treated nor control animals 30 and 54 hours after the challenge. Therefore, the substance should not be classified as sensitizating to skin.Hüls AG 1989
The skin sensitization potential of the substance was determined in a Guinea pig maximization test with groups of 20 (treated) or 10 (control) Guinea pigs.
A series of three intermal injections were carried out, with the test item at 20% in corn oil, a 1:1 mixture of Freund's Complete Adjuvant (FCA) with the test item at 20% in corn oil, and a 1:1 mixture FCA in water. Control animals received the same injections but without the test item.
One week later, a topical application of the test item at 100% or corn oil was conducted on the skin of the treated and control animals, following a pretreatment with 10 % sodium lauryl sulfate (SLS) in petrolatum
The challenge was conducted two weeks later using a patch loaded with 100% of the test item, applied for 24 hours.
Scoring of the cutaneous reaction was undertaken 24 and 48 hours after removal of the patch.
Weight loss was reported 10 to 14 days after the beginning of the experiment.
No cutaneous reaction was recorded in treated nor control animals 24 and 48 hours after the removal of the challenge patch. Therefore, the substance should not be classified as sensitizating to skin.IBR 1990
The skin sensitization potential of the substance was determined in a Guinea pig maximization test with 20 treated and 20 control Guinea pigs.
A series of three intermal injections were carried out, with the test item at 5% in paraffin oil, a 1:1 mixture of Freund's Complete Adjuvant (FCA) with the test item at 10% in paraffin oil (final concentration: 5%), and a 1:2 mixture FCA in water. Control animals received the same injections but without the test item.
One week later, a topical application of the test item at 100% or paraffin oil was conducted on the skin of the treated and control animals, following a pretreatment with 10 % sodium lauryl sulfate (SLS) in petrolatum.
The challenge was conducted two weeks later using a patch loaded with 100% of the test item, applied for 24 hours.
Scoring of the cutaneous reaction was undertaken 24 and 48 hours after removal of the patch.
No cutaneous reaction was recorded in treated nor control animals 24 and 48 hours after the removal of the challenge patch. Therefore, the substance should not be classified as sensitizating to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification for sensitisation is indicated according to the classification, labeling and packaging (CLP) regulation (EC 1272/2008).
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