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Diss Factsheets

Administrative data

Description of key information

The substance was not found to induce skin sensitisation in artificially sensitised guinea pigs (two Maurer optimisation tests).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 16, 1979 to September 6, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Maurer Optimization test in the guinea-pig
Version / remarks:
- Maurer Th., Thomann P., Weirich E.G., Hess R. - The Optimization test in the guinea-pig. Agents & Actions 5 (2), 174-179, 1975.
- Predictive evaluation in animals of the contact allergenic potential of medically important substances. Contact Dermatitis 4, 321-333, 1978. Contact Dermatitis 5, 1-10, 1979.
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
Study predates LLNA method
Species:
guinea pig
Strain:
other:
Remarks:
Pirbright-White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Ivanovas, Kissleg (later Charles River Kissleg), Germany
- Age at study initiation: ~10 weeks old
- Weight at study initiation: 375 to 485 g
- Housing: housed individually in Macrolon cages, type 3, assigned to the different groups by means of random numbers.
- Diet : The animals received ad libitum standard guinea pig pellets - NAFAG, N°. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55± 5%
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
10 * 0.1 ml of 0.1 % of test substance every other day (except weekends)
During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (Freund's complete Adjuvant) (vehicle : adjuvant =1 : 1).
Day(s)/duration:
Days 1, 3, 5, 9, 11, 13, 17, 19, 21, 25
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Remarks:
complete Bacto Adjuvant
Concentration / amount:
0.1 ml of a freshly prepared 0.1 % solution
Day(s)/duration:
14 days after last induction injection
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
3 % of test item in vaseline
Day(s)/duration:
10 days after intradermal challenge for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 per sex per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE INTRADERMAL
- No. of exposures: the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of test item in physiological saline. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs, one control group was treated with the vehicle alone
- Site: shaven skin of the right flank (only day 1) and the back
- Frequency of applications: every second day
- Duration: 10 intracutaneous injections (approximately 25 days)
- Concentrations: 0.1 % solution of test substance


B. CHALLENGE EXPOSURE
INTRADERMAL
- No. of exposures: single injection of 0.1 ml
- Day(s) of challenge: Fourteen days after the last induction injection
- Exposure period: single injection
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 0.1 % solution of test substance in physiological saline
- Evaluation (hr after challenge): Twenty-four hours after the challenge injection

EPIDERMAL
- No. of exposures: one
- Day(s) of challenge: ten days after the challenge injection
- Exposure period: 24 h
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 3 % of test substance in vaseline
- Evaluation (hr after challenge): Twenty-four hours after patch removal

OTHER:
Bodyweights were recorded immediately before starting the experiment (control values) and at termination of the study.

Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 ml of 0.1 % test item in physiological saline
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: intradermal challenge
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% of test item in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Remarks:
epidermal challenge
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20

No difference between the test and the control group was seen after epidermal challenge application.

Interpretation of results:
GHS criteria not met
Conclusions:
The negative results upon epidermal challenge demonstrate that, in artificially sensitised guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis. The substance is not considered to be a skin sensitiser.
Executive summary:

Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application of test substance, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The Maurer optimization test was used to investigate the sensitizing properties of Basic Red 46. The test was performed on 10 male and 10 female guinea pigs per group of the Pirbright white strain. During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of Basic Red 46 in physiological saline. One control group was treated with the vehicle alone ("negative control"). On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Freund’s Adjuvant (vehicle : adjuvant = 1 : 1).

Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of Basic Red 46 in physiological saline was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.

Ten days after the intracutaneous challenge injection a sub-irritant dose of the test compound (3 % Basic Red 46 in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 h after removing of the bandages according the Draize scoring scale.

Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after intradermal challenge application of Basic Red 46, i.e. when the skin barrier was intentionally by-passed. No differences between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Not classifiable