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Diss Factsheets

Administrative data

Description of key information

This key study determined the potential of the test substance to be sensitising to skin. Ten male and ten 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 sensitising.

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:
January 14, 1985-February 7, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.
Qualifier:
according to guideline
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.
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

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
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
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
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 chemical
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.
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.

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

Sensitisation data is from single OECD guideline 406 study which found the test substance is not sensitising to skin.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No positive reactions were noted in this guideline study, no classification was needed.