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Diss Factsheets

Administrative data

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 accoring to 96/54/EG, B.6 (GPMT). GLP study
Qualifier:
according to guideline
Guideline:
other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Himalayan
Sex:
not specified
Details on test animals and environmental conditions:
SPF animals.
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1 % aqueous CMC
Concentration / amount:
Induction: Intradermal: 2% test substance in 1 % aqueous CMC; Epidermal: 50 % test substance in 1 % aqueous CMC.
Challenge: 50 %.
Route:
other: not specified.
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1 % aqueous CMC
Concentration / amount:
Induction: Intradermal: 2% test substance in 1 % aqueous CMC; Epidermal: 50 % test substance in 1 % aqueous CMC.
Challenge: 50 %.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS: Maximum concentration not causing irritating effects in preliminary test: 50 %.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 10 animals in test group, 5 animals in negative control.
- Concentrations: Intradermal induction: 2% test substance in 1 % aqueous CMC; Epidermal induction: 50 % test substance in 1 % aqueous CMC.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Concentrations: 50 %.
- Evaluation: 24 and 48 hours
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

Intradermal exposure:

In all animals of the treatment group redness (grade 1 -3) was observed, which was enhanced by treatment with SDS.

Epidermal exposure:

2 of 5 control animals showed a slight scab formation.

2 other control animals showed scaliness of the skin.

All treated animals showed substance related brown staining of the skin.

3 of 10 treated animals showed additionally slight scab formation.

In 1 of 10 treated animals a slight erythema.

In 1 other test animal a severe erythema and scab was observed.

Oedema were observed nor in the test animals neither in the control animals.

Evidence of sensitisation of each challenge concentration:

None of the animals showed effects of sensitisation.

Other observations: none

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the Guinea Pig Maximisation Test none of the experimental animals showed effects of sensitisation.
Executive summary:

A sensitization study was performed according to 96/54/EG, B.6. (GMPT) under GLP conditions. Guinea pigs were intradermal (test substance in 1% aqueous carboxymethyl cellulose) and epidermal induced (50 % test substance in 1 % aqueous carboxymethyl cellulose). Then guinea pigs were challenged with test substance at 50% and no evidence of sensitization was seen in any of the tested animals.

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

Key study: A sensitization study was performed according to 96/54/EG, B.6. (GMPT) under GLP conditions. Guinea pigs were intradermal (test substance in 1% aqueous carboxymethyl cellulose) and epidermal induced (50 % test substance in 1 % aqueous carboxymethyl cellulose) to develop a hypersensitive state. After a induction period guinea pigs were challenged with test substance at 50% and no evidence of sensitization was seen in any of the tested animals.


Migrated from Short description of key information:
Key study: Test method EU Method B.6 (GPMT). GLP study. The substance was determined to be not skin sensitizer.

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

Justification for classification or non-classification

Based on available data, the substance is not classified for skin sensitization according to CLP Regulation (EC) No 1272/2008.