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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to guidelines and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A skin sensitisation study according to OECD 406 with adequate quality was already available, and therefore a further LLNA study was not needed to be developed.

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 Limited, Burton-on-Trent, Staffordshire, U.K.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 310 - 396g
- Housing: housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to mains tap water and food (Guinea Pig FDI Diet, Special Diets Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 23
- Humidity (%): 56-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.
No. of animals per dose:
10 animals+ 5 in control
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on results from triethanolamine, the major constituent of the multiconstituent substance, it is concluded that the substance is a weak sensitiser, no labelling is required.