Registration Dossier
Registration Dossier
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EC number: 438-600-3 | CAS number: 110675-26-8
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 110553-27-0
- Cas Number:
- 110553-27-0
- IUPAC Name:
- 110553-27-0
- Details on test material:
- - Batch #: Vers. 31-33
- Purity: pilot sample
- Storage: room temperature
- Physical state: liquid
- Expiry date: September 1991
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba Geigy Ltd. Tierfarm, Sisseln, Switzerland
- Age at study initiation: no data
- Mean weight at study initiation: males = 382.7 g; females = 376.1 g
- Housing: housed individually in Macrolon cages (Type 3)
- Diet: ad libitum; standard guinea pig pellets -NAFAG No.847, Gossau SG (assayed for nutritive ingredients and contamination level by the manufacturer)
- Water: ad libitum (drinking water was examined periodically by the IWB (Industrielle Werke Basel)
- Acclimation period: 8 days
- Rationale for choice: The albino guinea pig is the recommended species for skin sensitization studies.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil (Intradermal induction), Vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1%
epicutaneous induction: 30%
challenge: 3%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil (Intradermal induction), Vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1%
epicutaneous induction: 30%
challenge: 3%
- No. of animals per dose:
- Test group : 20 animals
control group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
Separate animals were treated with the test article for the evaluation of the primary irritation threshold concentration. 10 % in Vaseline induced erythema reactions. 3 % in Vaseline did not induce skin reactions and, therefore, this concentration was used as the maximal sub-irritant concentration for the challenge applications.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection
- Site/Area: Neck region/2 x 4 cm
- No. of injections/animal: 3 pairs
- Test substance group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with physiol. saline
- Test substance group (middle; 2 injections side by side): The test article (1%) in sesame oli
- Test substance group (caudal; 2 injections side by side): Freund's complete adjuvant blended (1:1, v/v) with physiol. saline + 1 % test article in vehicle.
- Control group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with physiol. saline
- Control group (middle; 2 injections side by side): Sesame oil
- Control group (caudal; 2 injections side by side): Freund's complete adjuvant blended (1:1, v/v) with physiol. saline + 1 % test article in vehicle.
- Volume per injection: 0.1 ml
- Evaluation (hr after injection): from 24 hour till day 7
- Exposure period: Single exposure
Epicutaneous induction exposure
- Time schedule: 1 week after intradermal injection
- Site: same site as intradermal injections
- Frequency of applications: Once.
- Area of application: 2 x 4 cm (filterpaper patch)
- Concentrations: 30% (test group), vehicle (control group)
- Amount applied: approx. 0.4 g paste of test substance in vaseline
- Type of coverage: occlusive
- Duration: 48 hours
- Evaluation (hr after challenge): directly after removal of patch
B. CHALLENGE EXPOSURE (all animals i.e treated animals and control animals)
- Time schedule: 2 weeks after termination of epicutaneous induction exposure
- Site: flank
- Area of application: 2 x 2 cm (filterpaper patch)
- Concentrations: 3%
- Amount applied: 0.2 g paste of test substance in vaseline (one flank) and vaseline (other flank)
- Type of coverage: occlusive
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
B.2. RECHALLENGE EXPOSURE
After the standard challenge exposures, 6 animals of the test group showed very slight skin reactions 24 and 48 hours. Because all the reactions observed were mild, a second challenge application was performed after a further period of 1 week.
SCORING SYSTEM: Draize in Appraisal of the Safety of chemicals in Foods, Drugs and Cosmetics (1959), The US Association of Food and Drug Officials (AFDO).
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4 - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the assay was checked every six months with Paraphenylene-diamine or Potassium-dichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Average body weights at termination
- males = 656 g
- females = 526.1 g
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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