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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 14, 1985-February 7, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981; Directive 179/831 Annex, Part B
GLP compliance:
yes
Type of study:
other: maximization test
Justification for non-LLNA method:
Data from LLNA method not available; study not required based on availability of more definitive in vivo data.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200-350 g
- Housing: Makrolon cages, 5 per cage
- Diet (e.g. ad libitum): 8GP17 guinea pig food, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degree C
- Humidity (%): 60 +/- 20%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intracutaneously and epicutaneously
Vehicle:
water
Concentration / amount:
Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water
Challengeopen allclose all
Route:
other: no data
Vehicle:
water
Concentration / amount:
Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water
No. of animals per dose:
10 male and 10 female
Details on study design:
Induction
Induction was first done by intradermal injection. Test animals were injected with 0.1 ml Freund Complete Adjuvant (FCA), 0.1 ml of 25% test substance in water, and 0.1 ml test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On day 7, a second, epicutaneous challenge was done. 0.5 ml of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were than bandaged, and the test substance remained in contact for 48 hrs. Control animals were exposed to vehicle only.

Challenge
0.2 ml of 12.5 % test article was placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 hrs. Observations for irritation were made at 24 and 48 hrs after the end of exposure. Skin was scored for irritation using the Draize scale.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 ml of 12.5% test solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no positive responses were observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no positive responses were observed.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not sensitizing to skin.
Executive summary:

This test determined the potential of the test substance to be sensitizing to skin. 10 male and 10 female guinea pigs were given intradermal injections of 25% test solution. Control animals (5 male and 5 female) were given injections of vehicle only. One week later, a second induction was done by dermal exposure to 25% test solution for 24 hrs. Control animals were again exposed to vehicle only. On day 21, the challenge exposure was performed. All animals were exposed to 12.5% test solution dermally. Exposure was for 24 hrs, with observations made at 48 and 72 hrs after the start of exposure. No positive reactions were noted. The test substance is not sensitizing.