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EC number: 701-140-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5th of December, 1988 to 5th of January, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted testing guideline
- Justification for type of information:
- Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- Test conducted according to the publication: "Allergic Contact Dermatitis in the Guinea pig: Identification of Contact Allergens" Mangusson B. Kligman A.M., 1970.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo studies can still be used to fulfil the information requirement at any tonnage level.
Test material
- Reference substance name:
- Similar substance 01 of Acid Brown 191
- IUPAC Name:
- Similar substance 01 of Acid Brown 191
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Source: Kleintierfarm Madoerin AG
Age at study initiation: (♂) 7 weeks; (♀) 8 weeks
Weight at study initiation: (♂) 416 - 461 g; (♀) 409 - 459 g
Housing: Individually in Makrolon cages type-3 with standard softwood bedding ("Lignocel", Schill AG)
Diet : Ad libitum Pelletted standard Kliba 342, Batch 47/88 guinea pig breeding/ maintenance diet
Water (e.g. ad libitum): Ad libitum community tap water from Itingen
Acclimation period: One week under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
Temperature (°C): 22 ± 3 °C
Humidity (%): 40 - 70 %
Air changes (per hr): 10 - 15
Photoperiod (hrs dark/hrs light): 12/12, music during the light period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- PRELIMINARY STUDYIntradermal injection: 0.1, 0.3, 0.5, 1, 3 and 5 % of test article in petrolatum oil (0.1 ml/site)Epidermal application: 3, 5, 10 and 25 % of test article in petrolatum oilMAIN STUDY - INDUCTIONIntradermal injection: - Freunds' complete adjuvant 50:50 with bidistille water- 0.5 % of test article in petrolatum oil (0.1 ml/site)- 0.5 % of test article emulsified in a 50:50 mixture of Freunds complete adjuvant, and petrolatum oilEpidermal Application (1 week after injections): 5 % in petrolatum oilMAIN STUDY - CHALLENGE3 % in petrolatum oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- PRELIMINARY STUDYIntradermal injection: 0.1, 0.3, 0.5, 1, 3 and 5 % of test article in petrolatum oil (0.1 ml/site)Epidermal application: 3, 5, 10 and 25 % of test article in petrolatum oilMAIN STUDY - INDUCTIONIntradermal injection: - Freunds' complete adjuvant 50:50 with bidistille water- 0.5 % of test article in petrolatum oil (0.1 ml/site)- 0.5 % of test article emulsified in a 50:50 mixture of Freunds complete adjuvant, and petrolatum oilEpidermal Application (1 week after injections): 5 % in petrolatum oilMAIN STUDY - CHALLENGE3 % in petrolatum oil
- No. of animals per dose:
- PRELIMINARY STUDY
Intradermal injection: 1 animal per sex per dose
Epidermal application: 4 concentrations per animal
MAIN STUDY
10 animal per sex per dose - Details on study design:
- PRELIMINARY STUDY
A. INTRADERMAL INJECTION
Concentrations: 0.1, 0.3, 0.5, 1, 3 and 5 % of the test item in petrolatum oil
Exposure period: 24 hours- Volume of injection: 0.1 ml/site
B. EPIDERMAL APPLICATION
Area of exposition: 2 x 2 cm patches of filtred paper satured with petrolatum oil and test item solution
Concentrations: 3, 5 10 and 25 % of the test item in petrolatum oil
Type of coverage: Occlusive, the patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wound round the trunk and covered with impervious adhesive tape.
Exposure time: 24 hours
MAIN STUDYA. INDUCTION EXPOSURE
intradermal injection
No. of exposures: three pairs of intradermal injection
Test groups: 10 male and 10 female
Control group: 5 male and 5 female, omission fo the test article
Site: area of dorsal skin from the scapular region (6 x 8 cm) clipped free of hair
Concentrations: (1) Freunds' complete adjuvant 50:50 with bidistille water; (2) 0.5 % of test article in petrolatum oil (0.1 ml/site); (3) 0.5 % of test article emulsified in a 50:50 mixture of Freunds complete adjuvant, and petrolatum oil
B. INDUCTION EXPOSURE
Epidermal application (1 week after injection)
Area of exposition: 2 x 4 cm patches of filtred paper satured with petrolatum oil and test item solution applied to the scapular area slipped and shaved free of hair (6 x 8 cm)
Concentrations: 5 % of the test item in petrolatum oil
Type of coverage: Occlusive, the patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wound round the trunk and covered with impervious adhesive tape.
Exposure time: 48 hours
Test groups: 10 male and 10 female
Control group: 5 male and 5 female, omission fo the test article
Evaluation of erythema and oedema: immediately, 24 and 48 hours after the removal of the patched
C. CHALLENGE EXPOSURE
2 weeks after the epidermal application)
Area of exposition: two patches (2 x 2 cm) of filtred paper satured with petrolatum oil and test item and with petrolatum oil were applied to the scapular area slipped and shaved free of hair (5 x 5 cm) of each guinea pig.
Exposure period: 24 hours
Test groups: 10 male and 10 female
Control group: 5 male and 5 female, omission fo the test article
Concentrations: 3 % of the test item in petrolatum oil
Evaluation (hr after challenge): immediately, 24 and 48 hours after the removal of the patched - Challenge controls:
- Each Guinea pig were treated with: a) non-irritant concentration (3 % in petrolatum oil) of the test article on the left flankb) vehicle alone on the right flank
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitro-benzol (DNCB)
Results and discussion
- Positive control results:
- Positive erythema reactions after first challenge procedure: 67 % Strong skin sensitizing potential in the guinea pig strain used
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 3 % of test article in petrolatum oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- See below
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 0.0. Group: test group. Dose level: 3 % of test article in petrolatum oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: See below.
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 % of test article in petrolatum oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- See below
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 24.0. Group: test group. Dose level: 3 % of test article in petrolatum oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: See below.
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 % of test article in petrolatum oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- See below
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 48.0. Group: test group. Dose level: 3 % of test article in petrolatum oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: See below.
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- Petrolatum oil alone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- See below
- Remarks on result:
- other: Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 0.0. Group: negative control. Dose level: Petrolatum oil alone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: See below.
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Petrolatum oil alone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- See below
- Remarks on result:
- other: Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 24.0. Group: negative control. Dose level: Petrolatum oil alone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: See below.
- Reading:
- other: Skin response after the first challenge procedure
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Petrolatum oil alone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- See below
- Remarks on result:
- other: Reading: other: Skin response after the first challenge procedure. . Hours after challenge: 48.0. Group: negative control. Dose level: Petrolatum oil alone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: See below.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
SENSITIZING EFFECTS
Vehicle control:
No positive reactions were evident after the first challenge application.
Test article:
No positive reactions were evident after the first challenge application.
Due to the unequivocal findings observed after the first challenge, no second challenge was performed.
VIABILITY / MORTALITY
No death occurred
SYMPTOMS, LOCAL
Vehicle control:
Application area around the injection sites 1, 2 and 3 were found to show edema and erythema from day 2 to day 8. Necroses were observed from day 10 to 25 (termination of test).
Test Article:
The animals of the test article-treated group were found to show the same reactions as described above. Additionally discoloration on the treated skin was observed from day 3 to 5 and day 10 to 16.
At the day 9 of test no observation could be performed because the animals were treated semi-occlusively.
SYMPTOMS, SYSTEMIC
No systemic simptoms were observed.
BODY WEIGHTS
Animals n. 916, 917, 918 and 927 (♀) were found to show emaciation during acclimatization.
The body weight gain of all other animals was not affected during the test.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified as a skin sensitiser according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Not sensitising
- Executive summary:
Method
The test has been conducted in according to the GLP procedure and in according to the following guidelines:
OECD Guideline 406, EU Method B.6 and "Allergic Contact Dermatitis in the Guinea pig: Identification of Contact Allergens" Mangusson B. Kligman A.M., 1970 published by C. C. Thomas, Springfiels, Illinois, U.S.A.
Observations
Ten animals (5 per sex) were treated with the vehicle alone (petrolatum oil) and 20 animals (10 per sex) were treated with the test article in petrolatum oil.
No systemic symptoms have been recorded but local symptoms were observed: The animals of the negative control group showed oedema and erythema from day 2 to day 8 on the application area around the injection sites 1, 2 and 3. Necrosis were observed from day 10 to 25 (termination of test).
The animals of the test article-treated group were found to show the same reactions as described above. Additionally discoloration on the treated skin was observed from day 3 to 5 and day 10 to 16.
Nevertheless during the first challenge procedure no positive reactions were evident and no deaths occurred.
Results
The test item does not show any allergenic potential under the test condition.
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