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Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD 406. GLP study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Dunkey-Hartley Crl: (HA)BR
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
other: 0.9 % NaCl
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.
Concentration of test material and vehicle used for each challenge:
Epidermal application: substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
Route:
other: Epidermal application.
Vehicle:
other: 0.9 % NaCl
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.
Concentration of test material and vehicle used for each challenge:
Epidermal application: substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
No. of animals per dose:
Number of animals in test group: 20
NUmber of animals in negative control group: 10
Details on study design:
RANGE FINDING TESTS: Maximum concentration which did not caused irritating effects in preliminary tests: 10 %.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 20 animals.
- Control group: 10 animals.
- Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 20 animals
- Control group: 10 animals
-Concentration of test material and vehicle used for each challenge:
Epidermal application: Substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
- Evaluation: 2 readings were made, 24 and 48 hours after challenge
Challenge controls:
no data.
Positive control substance(s):
not specified
Positive control results:
no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0.

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:

With intradermal injection on day 1 (concentration selected according to the results of the pretests).

With epidermal application of the substance on day 8 (during 48 hours).

Evidence of sensitisation of each challenge concentration:

The substance causes delayed contact hypersensitivity in 15/20 (75 %) of the animals.

Due to the substance, a yellowish discoloration of the treated area of the body was observed in all of the animals from both of the groups. It could have hidden a possible separate or moderate erythema (grade 1 or 2) in some of the animals at the 24-h measurement value. Dryness of the skin was observed in 3/10 of the animals from the control group at the 48-h measurement value. The dryness of the skin is sometimes associated with scabs and/or oedemas. The dryness of the skin was observed in 16/20 of the animals from the treated group at the 48-h measurement value.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions the substance caused delayed contact hypersensitivity in 75 % of the animals.
Executive summary:

A Guinea Pig Maximisation test was conducted according to OECD guideline 406 and EU method B.6. Dunkey-Harley guinea pigs were induced to develop a hipersensitive state by intradermal injections of 1 % of the test substance in 0.9 % NaCl, with this intradermal injection there were signs of irritation. On day 8 animals were re-induced through an epidermal application of the test substance at 10 % (g/g) in 0.9 % NaCl, there were signs of irritation. The challenge phase of the experiment was performed through an epidermal application of the substance at a concentration of 10 % (g/g) in 0.9 % NaCl. The test substance caused delayed contact hypersensitivity in 15/20 (75%) of the animals.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Key study: A Guinea Pig Maximisation test was conducted according to OECD guideline 406 and EU method B.6 under GLP conditions. Dunkey-Harley guinea pigs were induced to develop a hipersensitive state by intradermal injections of 1 % of the test substance in 0.9 % NaCl, with this intradermal injection there were signs of irritation. On day 8 animals were re-induced through an epidermal application of the test substance at 10 % (g/g) in 0.9 % NaCl, there were signs of irritation again. The challenge phase of the experiment was performed through an epidermal application of the substance at a concentration of 10 % (g/g) in 0.9 % NaCl. The test substance caused delayed contact hypersensitivity in 15/20 (75%) of the animals.


Migrated from Short description of key information:
Key study: Test method according to OCED guideline 406 under GLP conditions. The test substance caused delayed contact hypersensitivity in 75% of the animals.

Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation: Given that 75% of the animals developed delayed contact hypersensitivity and the intradermal induction was at 1 %, the substance can be classified as skin sensitizer (Category 1A).