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EC number: 619-020-1 | CAS number: 94361-06-5
Endpoint summary
Administrative data
Description of key information
- Skin sensitisation: not sensitising, male/female, Guinea pig, OECD 406 (Buehler), Durando 2005
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:
- key study
- Study period:
- 26 Jul 2005 to 31 Aug 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200, January 28
- Version / remarks:
- 1985
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult
- Weight at study initiation: 298-460 g at experimental start
- Housing: The animals were group housed in suspended stainless steel caging with mesh floors or plastic perforated bottom caging which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Water: ad libitum
- Acclimation period: 10 or 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: 26 Jul 2005 to 31 Aug 2005 - Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Day(s)/duration:
- Day 0, 7, and 14: Occlusive dressing for 6 hours
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water) in test animals
- Day(s)/duration:
- Day 27: Evaluation for a sensitization response after 24 and 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water in naive control animals
- Day(s)/duration:
- Day 27: Evaluation for a sentization response after 24 and 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary Irritation Group: 4
Test Group: 20
Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Control group: Untreated
- Site: The left side of each test animal using an occlusive 25 mm Hill Top Chamber
- Frequency of applications: Once each week for three weeks
- Concentrations: Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
B. CHALLENGE EXPOSURE
- Test groups: Test Animals (75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Control group: Naive Control Animals (75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Site: On the right side of each test animal
- Concentrations: Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Evaluation (hr after challenge): 24 and 48 hours
OTHER:
Body weight: Individual body weights of the animals were recorded prior to the initial induction and again the day after the challenge application. - Challenge controls:
- Not performed
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
- Positive control results:
- The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde (HCA) validates the test system used in this study
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Irritation cleared from all affected sites by 48 hours.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Naive Control Animals. Irritation cleared from all affected sites by 48 hours.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 75% w/w mixture of HCA in mineral oil
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- Faint to very faint erythema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- persisting at 48h
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% w/w mixture of HCA in mineral oil
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Historical Naive Control Animals. Irritation persisted at one of these sites through 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these findings and on the evaluation system used, the test substance is not considered to be a contact sensitizer.
- Executive summary:
In a study performed in accordance with OECD TG 406 and GLP principles, a dermal sensitization test was conducted with guinea pigs to determine the potential of the test substance to produce sensitization after repeated topical applications. A 75% w/w mixture of the test substance in a 1% w/w solution of carboxymethylcellulose (CMC) in distilled water was topically applied to twenty guinea pigs, once each week for a three-week induction period. Twenty-seven days after the first induction dose, a challenge dose of the test substance at its highest non- irritating concentration (HNIC, determined in the preliminary irritation screen to be a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water) was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the test substance at challenge only. Approximately 24 and 48 hours after each induction and challenge application the animals were scored for a sensitization response (erythema).
The test animals and naive control animals showed no incidences of positive response (scores greater than 0.5 after 24 and 48 hours. The test animals showed a severity of 0.13 and the naive control animals showed a severity of 0.15 ( Sum of the erythema scores divided by the number of animals evaluated).
Based on the results of this study, the test substance is not considered to be a contact sensitizer. The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde Technical (HCA) validates the test system used in this study.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 3 Dec 1991 to 3 Jan 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson B. Kligman A.M., Identification of Contact Allergens by animal assay. The guinea pig maximization, test. J. Invest. Dermatol. 52: 268-276.
- Version / remarks:
- 1969
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The GPMT test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: Control and test group: 396 - 473 g, pretest: 408 - 457 g
- Housing: Individually in Makrolon type-3 cages (size: 27 x 42 x 15 cm) with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: One week for the control and test group under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: 3 Dec 1991 to 3 Jan 1992 - Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Test group and control group
Treatment: Freund's complete adjuvant 50:50 with physiological saline - Day(s)/duration:
- Day 0: First injection out of the three pairs of intradermal injections (Test group and control group), third injection out of the three pairs of intradermal injections (Control group)
- Route:
- intradermal
- Vehicle:
- DMSO
- Concentration / amount:
- Test group
The test substance, diluted to 5% with DMSO - Day(s)/duration:
- Day 0: Second injection out of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- DMSO
- Concentration / amount:
- Test group
Treatment: The test substance diluted to 5% by emulsion in a 50:50 mixture of Freund's complete adjuvant and physiological saline. - Day(s)/duration:
- Day 0: Third injection out of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- DMSO
- Concentration / amount:
- Control group
Treatment: Control (DMSO only) - Day(s)/duration:
- Day 0: Second injection out of the three pairs of intradermal injections
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- Test group:
Patch: 2 x 4 cm (filter paper)
Treatment: Application of the test substance 25% in DMSO
24 hours after pre-treatment with 10% sodium-laurylsulfate - Day(s)/duration:
- Day 8: Occlusive dressing for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- Control group:
Patch: 2 x 4 cm (filter paper)
Treatment: DMSO only, 24 hours after pre-treatment with 10% sodium-laurylsulfate - Day(s)/duration:
- Day 8: Occlusive dressing for 48 hours
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- A non-irritant concentration of the test substance, 25% in DMSO (0.1 mL)
- Day(s)/duration:
- 24 hour
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- DMSO only (0.1 mL)
- Day(s)/duration:
- 24 hour
- No. of animals per dose:
- Control group: 10 females
Test group: 20 females
Intracutaneous pretest: 2 females
Epicutaneous pretest: 4 females - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
Intadermal injections:
- Site: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair
- Duration: 8 days
Test group:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) The test article, diluted to 5% with DMSO.
3) The test article diluted to 5% by emulsion in a 50:50 mixture of
Freund's complete adjuvant and physiological saline.
Control Group:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) DMSO
3) Freund's complete adjuvant 50:50 with physiological saline.
Epidermal applications:
- Site: The scapular area (approximately 6 x· 8 cm). The test are was pre treated with 10% sodium-lauryl-sulfate (SLS) in petrolatum oil. The SLS was massaged into the skin with a glass rod without bandaging. On day 8 of the test a 2 x 4 cm patch of filter was covered with a thin layer of the test substance (25% in DMSO) and placed over the injection sites of the animals.
- Duration: 48 hour
B. CHALLENGE EXPOSURE
- Day(s) of challenge: The test and control guinea-pigs were challenged two weeks after the epidermal induction application.
- Exposure period: 24 hour
- Site: Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig
- Concentrations:
a) a non-irritant concentration of the test article (25% in DMSO applied to the left flank using the same method as for the epidermal application
b) with DMSO only applied to the right flank using the same method as for the epidermal application
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing using the numerical scoring system according to Draize.
OTHER:
Clinical observations: Daily
Body weight observations: At acclimatization start, at day one and at termination of test
Viability/Mortality observations: Daily - Challenge controls:
- DMSO
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol
- Positive control results:
- According to the procedures used in this experiment (run from December 2, 1991 to January 2, 1992) clear positive results were observed in the treated animals
after the epidermal challenge application. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- DMSO only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- DMSO only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- DMSO only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- DMSO only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2-Mercaptobenzothiazol
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Positive reaction
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2-Mercaptobenzothiazol
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Positive reaction
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered not to be a sensitizer.
- Executive summary:
In a study that was performed in accordance with OECD TG 406 and GLP principles, the allergenic potential of the test substance was assessed in albino guinea pigs using the Maximization-Test of B. Magnusson and A.M. Kligman (1969). Ten females were used as control group and 20 females were used as test group. Due to the unequivocal findings observed after the first challenge, no second challenge was performed. The highest non-irritating concentration used for challenge application was 25%.
Epidermal induction caused grade 1 erythema in 8 of 20 animals and in 2 of 20 animals after 24 and 48 hours, respectively. 24 and 48 hours after challenge application, no positive reactions were evident at the application site in any of the animals. No toxic symptoms were evident in the guinea pigs of the control or test group.
The test substance is considered as non-sensitising in this maximisation test. No classification is required.
Referenceopen allclose all
Table 1. Body weights (test substance)
Animal No. |
Sex |
Initial (g) |
Day after Challenge (g) |
26864 |
M |
437 |
558 |
26865 |
M |
416 |
502 |
26866 |
M |
421 |
642 |
26867 |
M |
392 |
605 |
26868 |
M |
413 |
680 |
26869 |
M |
426 |
633 |
26870 |
M |
460 |
643 |
26871 |
M |
412 |
647 |
26872 |
M |
396 |
546 |
26873 |
M |
374 |
533 |
26874 |
M |
427 |
613 |
26875 |
M |
416 |
558 |
26876 |
M |
410 |
588 |
26877 |
M |
439 |
606 |
26878 |
M |
378 |
544 |
26879 |
M |
391 |
596 |
26880 |
M |
361 |
597 |
26881 |
M |
360 |
573 |
26882 |
M |
364 |
498 |
26883 |
M |
353 |
496 |
Table 2. Body weights (naive group)
Animal No. |
Sex |
Initial (g) |
Day after Challenge (g) |
26884 |
M |
386 |
559 |
26885 |
M |
369 |
590 |
26886 |
M |
394 |
512 |
26887 |
M |
387 |
557 |
26888 |
M |
362 |
533 |
26889 |
M |
391 |
604 |
26890 |
M |
333 |
565 |
26891 |
M |
298 |
467 |
26892 |
M |
416 |
649 |
26893 |
M |
394 |
620 |
Table 3. Induction phase skin reactions scores (test substance)
Induction Number |
1 |
2 |
3 |
|||
Concentration1 |
75% |
75% |
75% |
|||
Amount Applied(g) |
0.4 |
0.4 |
0.4 |
|||
Hours2 |
24 |
48 |
24 |
48 |
24 |
48 |
Animal No. |
|
|||||
26864 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
26865 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26866 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26867 |
0 |
0 |
0 |
0 |
0 |
0 |
26868 |
0.5 |
0 |
0.5 |
0 |
0.5 |
0 |
26869 |
0 |
0 |
0 |
0 |
0 |
0 |
26870 |
0 |
0 |
0 |
0 |
0 |
0 |
26871 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26872 |
0 |
0 |
0 |
0 |
0.5 |
0 |
26873 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26874 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26875 |
0 |
0 |
0 |
0 |
0 |
0 |
26876 |
0 |
0 |
0 |
0 |
0 |
0 |
26877 |
0 |
0 |
0 |
0 |
0 |
0 |
26878 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26879 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26880 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26881 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
26882 |
0 |
0 |
0 |
0 |
0 |
0 |
26883 |
0.5 |
0 |
0 |
0 |
0 |
0 |
1 Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water was applied.
2 Hours after induction dose.
Table 4. Challenge phase skin reactions scores (test substance)
Animal No. |
Hours after Application |
|
24 |
48 |
|
26864 |
0.5 |
0 |
26865 |
0 |
0 |
26866 |
0 |
0 |
26867 |
0 |
0 |
26868 |
0.5 |
0 |
26869 |
0 |
0 |
26870 |
0 |
0 |
26871 |
0 |
0 |
26872 |
0 |
0 |
26873 |
0 |
0 |
26874 |
0 |
0 |
26875 |
0 |
0 |
26876 |
0 |
0 |
26877 |
0 |
0 |
26878 |
0 |
0 |
26879 |
0.5 |
0 |
26880 |
0 |
0 |
26881 |
0 |
0 |
26882 |
0.5 |
0 |
26883 |
0.5 |
0 |
Table 5. Challenge phase skin reactions
scores (test substance), naive control group
Animal No. |
Hours after Application |
|
24 |
48 |
|
26884 |
0.5 |
0 |
26885 |
0 |
0 |
26886 |
0 |
0 |
26887 |
0 |
0 |
26888 |
0 |
0 |
26889 |
0.5 |
0 |
26890 |
0 |
0 |
26891 |
0 |
0 |
26892 |
0 |
0 |
26893 |
0.5 |
0 |
Table 1. Positive erythema after first challenge procedure
GROUPS |
after 24 hours |
after 48 hours |
Positive / total % positive of total |
Positive / total % positive of total |
|
CONTROL 25% of the test substance (left flank)
|
0/10 ------ 0 |
0/10 ------ 0 |
DMSO (right flank) |
0/10 ------ 0 |
0/10 ------ 0 |
TEST 25% of the test substance (left flank) |
0/20 ------ 0 |
0/20 ------ 0 |
DMSO |
0/20 ------ 0 |
0/20 ------ 0 |
Table 2. Skin response after the first challenge procedure with DMSO (right flank)
Animal number |
Sex |
Erythema/oedema-readings after removal of bandage |
|||
24 hours |
48 hours |
||||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
411 |
female |
0 |
0 |
0 |
0 |
412 |
female |
0 |
0 |
0 |
0 |
413 |
female |
0 |
0 |
0 |
0 |
414 |
female |
0 |
0 |
0 |
0 |
415 |
female |
0 |
0 |
0 |
0 |
416 |
female |
0 |
0 |
0 |
0 |
417 |
female |
0 |
0 |
0 |
0 |
418 |
female |
0 |
0 |
0 |
0 |
419 |
female |
0 |
0 |
0 |
0 |
420 |
female |
0 |
0 |
0 |
0 |
421 |
female |
0 |
0 |
0 |
0 |
422 |
female |
0 |
0 |
0 |
0 |
423 |
female |
0 |
0 |
0 |
0 |
424 |
female |
0 |
0 |
0 |
0 |
425 |
female |
0 |
0 |
0 |
0 |
426 |
female |
0 |
0 |
0 |
0 |
427 |
female |
0 |
0 |
0 |
0 |
428 |
female |
0 |
0 |
0 |
0 |
429 |
female |
0 |
0 |
0 |
0 |
430 |
female |
0 |
0 |
0 |
0 |
Table 3. Skin response after the first challenge procedure with the test article (25%) in DMSO (left flank)
Animal number |
Sex |
Erythema/oedema-readings after removal of bandage |
|||
24 hours |
48 hours |
||||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
411 |
female |
0 |
0 |
0 |
0 |
412 |
female |
0 |
0 |
0 |
0 |
413 |
female |
0 |
0 |
0 |
0 |
414 |
female |
0 |
0 |
0 |
0 |
415 |
female |
0 |
0 |
0 |
0 |
416 |
female |
0 |
0 |
0 |
0 |
417 |
female |
0 |
0 |
0 |
0 |
418 |
female |
0 |
0 |
0 |
0 |
419 |
female |
0 |
0 |
0 |
0 |
420 |
female |
0 |
0 |
0 |
0 |
421 |
female |
0 |
0 |
0 |
0 |
422 |
female |
0 |
0 |
0 |
0 |
423 |
female |
0 |
0 |
0 |
0 |
424 |
female |
0 |
0 |
0 |
0 |
425 |
female |
0 |
0 |
0 |
0 |
426 |
female |
0 |
0 |
0 |
0 |
427 |
female |
0 |
0 |
0 |
0 |
428 |
female |
0 |
0 |
0 |
0 |
429 |
female |
0 |
0 |
0 |
0 |
430 |
female |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
All available data was assessed and the studies representing the worst-case effects were included as key studies. All other information was included as supporting information. The test substance is considered to be a non-sensitiser based on the results of the key and supporting studies.
Skin sensitisation
In the key study (Durando 2005) performed in accordance with OECD TG 406 and GLP principles, a dermal sensitization test was conducted with guinea pigs to determine the potential of the test substance to produce sensitization after repeated topical applications. A 75% w/w mixture of the test substance in a 1% w/w solution of carboxymethylcellulose (CMC) in distilled water was topically applied to twenty guinea pigs, once each week for a three-week induction period.Twenty-seven days after the first induction dose, a challenge dose of the test substance at its highest non- irritating concentration (HNIC, determined in the preliminary irritation screen to be a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water) was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the test substance at challenge only. Approximately 24 and 48 hours after each induction and challenge application the animals were scored for a sensitization response (erythema).
The test animals and naive control animals showed no incidences of positive response (scores greater than 0.5 after 24 and 48 hours. The test animals showed a severity of 0.13 and the naive control animals showed a severity of 0.15 ( Sum of the erythema scores divided by the number of animals evaluated).
Based on the results of this study, the test substance is not considered to be a contact sensitizer. The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde Technical (HCA) validates the test system used in this study.
One study is available as supporting information which supported the findings of the key study. The study (Arcelin 2009) was performed in accordance with OECD TG 406 and GLP principles. The highest non-irritating concentration used for challenge application was 25%. Epidermal induction caused grade 1 erythema in 8 of 20 animals and in 2 of 20 animals after 24 and 48 hours, respectively. 24 and 48 hours after challenge application, no positive reactions were evident at the application site in any of the animals. No toxic symptoms were evident in the guinea pigs of the control or test group. The test substance is considered as non-sensitising in this maximisation test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information classification for skin sensitisation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
