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Diss Factsheets

Administrative data

Description of key information

Based on the results obtained in a Optimization study the test item is considered to possess no skin-sensitizing (contact allergenic) potential in guinea pigs.

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:
1979-05-23-1979-06-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (US, 1959)
Deviations:
no
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
The study was conducted in 1979. By this time the LLNA was not an established method yet.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 350-440 grams
- Housing: Housed indivually in Macrolon cages, type 3
- Diet: NAFAG No. 830 Gossau SG

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Photoperiod: 10 hours light cycle day
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
0.1 %
Day(s)/duration:
day 0 - day 10
No.:
#1
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
0.1 %
Day(s)/duration:
day 24
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
30 %
Day(s)/duration:
day 34 / 24 h
No. of animals per dose:
10 males and 10 females per group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three different injection procedures+challenge exposure+epicutaneous application:
1. One injection every second day to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 %.
2. On the first day injection 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.
3. During the second and third week of the induction period the material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant.

- Test groups: groups of 10 male and 10 females
- Control group: one control group was treated with the vehicle alone
- Duration: 3 weeks

B. CHALLENGE EXPOSURE
- No. of exposures: 1: Fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 % was administered into the skin of the left flank.
- Evaluation (hr after challenge): 24 hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.

C.EPICUTANEOUS CHALLENGE:
Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The test substance was applicated in a dose of 30 % in Vaseline.
Positive control substance(s):
no
Positive control results:
no positive control
Key result
Reading:
other: 1st reading (intradermal challenge)
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 %
No. with + reactions:
7
Total no. in group:
19
Key result
Reading:
other: 1st reading (intradermal challenge)
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
4
Total no. in group:
20
Key result
Reading:
other: 1st reading (epicutaneous challenge)
Hours after challenge:
240
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
other: 1st reading (epicutaneous challenge)
Hours after challenge:
240
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
19

Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of the test item. The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

An optimization study with guinea pigs was performed to investigate the sensitization potential of the test item. The procedure was similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959). 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 % suspension of test material in propylene glycol. 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 (1:1). Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % suspension in propylene glycol was administered into the skin of the left flank. Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (30% in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of the test item. The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.