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Administrative data

Description of key information

in vivo skin sensitization, OECD 406, GPMT, not skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
Since December 12,1988 to January 5, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the validation of LLNA OECD method and is considered to be valid and acceptable for the assessment.
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: males : 7 weeks females: 8 weeks
- Weight at study initiation: males: 416 - 461 g females: 409 - 459 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet : Pelleted standard Kliba 342, Batch 47188 guinea pig breeding/ maintenance diet, ad libitum.
- Water: tap water , ad libitum.
- 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 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music/tight period.

Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.1, 0.3, 0.5, 1, 3 and 5 % of the test article in petrolatum
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.1, 0.3, 0.5, 1, 3 and 5 % of the test article in petrolatum
No. of animals per dose:
5 x sex x dose (control)
10 x sex x dose
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE: injection
- No. of exposures: 6
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/ site) were made at the border of a 4 x 6 cm area in the clipped region
- Concentrations: 0.1 , 0.3, 1, 3, and 5% test item in petrolatum


INDUCTION EXPOSURE: One week after the injections
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: (6 x 8 cm)
- Type of coverage: filter paper was saturated with the test article (5 % in petrolatum) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wound round the trunk of the animal and secured with impervious adhesive tape.
- Duration: 24 hours
- Concentrations: 5% in petrolatum

B. CHALLENGE EXPOSURE: The test and control guinea-pigs were challenged two weeks after the epidermal induction application.
- No. of exposures:2
- Exposure period: approximately 24 hours later
- Test groups:10 males and 10 females
- Control group:5 males and 5 females
- Site:hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig.
- Type of coverage: Two patches (2 x 2 cm) of filter paper
- Concentrations:3 % in petrolatum oil
- Evaluation : 0, 24, 48 hrs

OTHER OBSERVATION:
Mortality/Viability: Once daily
Body Weights: At acclimatization start, start of application and end of test.
Symptoms (local systemic): daily
Necropsy: no
All animals were killed at the end of the test period with an intraperitoneal injection of T61 (Hoechst AG) and discarded.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were observed.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were observed.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
6
Total no. in group:
9
Clinical observations:
none
Remarks on result:
other: A control group (Binitro-choloro-benzene) is tested twice a year as a sensitivity check of the guinea pig strain. The most recent test was run during September 1988.
Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The analogue substance was tested for skin sensitization following OECD 406. Under the experimental conditons the substance is not classified as skin sensitizer
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of the analogue substance when administered to the skin of male and female albino guinea pigs.

For this purpose the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten animals (5 males, 5 females) were treated with the vehicle alone (petrolatum oil) and 20 animals (10 males, 10 females) were treated with the test article.

The study was conducted between December 5th and January 5th, 1989 at the RCC laboratories in 4452 Itingen/Switzerland.

If necessary prior to the first reading of the reactions, the skin was flushed with the vehicle or other solvents to clean the application site from staining produced by the test article, so that the reactions (erythema) were clearly visible at that time. Due to the unequivocal findings observed after the first challenge, no second challenge was performed.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

skin sensitizer Cat 1A, with GPMT:

≥ 30 % is responsive to ≤ 0,1 % of the intradermal induction dose or

> 60 % is responsive to > 0,1 %- ≤ 1 % of the intradermal induction dose

 

skin sensitizer Cat 1B, with GPMT

≥ 30 % to < 60 % is responsive to > 0,1 % - ≤ 1 % of the intradermal induction dose or,

≥ 30 % is responsive to > 1 % of the intradermal induction dose

 

Based on the results of the skin sensitization test (GPMT) the analogue substance and the read across considerations, the substance is not classified as skin sensitizer