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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
July-September 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6 No info on batch no. and composition. Well reported and conducted study according to guideline/standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Date of receipt: 25 June and 28 August 1997
Appearance: clear yellow liquid
Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: 300-392 g
- Housing: singly or in pairs in polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 54-78
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From:30 July To: 3 September 1997

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100% (undiluted)
Challenge: 100% and 75% (v/v) in distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100% (undiluted)
Challenge: 100% and 75% (v/v) in distilled water
No. of animals per dose:
20 test and 10 control animals
Details on study design:
RANGE FINDING TESTS:
Induction (2 guinea pigs): 25, 50, 75 (v/v) and 100&% (undiluted); 100% was selected
Challenge: not done due to a lack of test material; 100% and 75% (v/v) were selected.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: days 0, 2, 4, 7, 9, 11, 14, 16 and 18
- Test groups: yes
- Control group: no (blank patch)
- Site: left flank
- Frequency of applications: 9 times
- Duration: 6 h each time
- Concentrations: 100% (undiluted)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 h
- Test groups: yes
- Control group: yes
- Site: right flank
- Concentrations: 100% (undiluted) and 75% (v/v)
- Evaluation (hr after challenge): 24 and 48 h after patch removal

Challenge controls:
Yes, silimar to test group
Positive control substance(s):
no

Results and discussion

Positive control results:
Not used.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, Ampholak YJH-40 is not a sensitiser to guinea pig skin.
Executive summary:

A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548/EEC). Twenty test and ten control animals were used for the main study.

Based on the results of a sighting test, the concentration of test material for the induction phase was selected as follows:

Topical Induction: undiluted as supplied;

Based on the results of the induction phases of the study the concentrations of test material for the challenge phase were as follows:

Topical Challenge : undiluted as supplied and 75% v/v in distilled water.

The test material produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to OECD/GHS.