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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
Study period:
1991-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was carried out in accordance with the OECD Guideline No. 406, *Skin Sensitisation*, the EEC Directive 84/449/EEC, Part 8.6, *Skin Sensitisation* and in accordance with the method described by Magnusson and Kligman, 'Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens. A GLP certificate is provided.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The testing using the guinea pig maximisation test protocol was completed on 17 April 2009. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
Preliminary study : 10 females
Experimental group: 20 females
Control group : 10 females
Route:
intradermal
Vehicle:
water
Route:
epicutaneous, occlusive
Vehicle:
water
Details on study design:
On day 1 an area of the dorsal skin from the scapular region (approximately 4 x 6 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mllsite) were made at the border of a 2 x 4 cm area in the clipped region as follows:

A) The test substance diluted to 0.1 % (wlw) with physiological saline,
B) Freunds' Complete Adjuvant (FCA, Difco, Detroit, U.S.A.), 50:50 with distilled water for injection (pyrogen free).
C) The test substance, at twice the concentration used in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
Positive control substance(s):
yes
Remarks:
Formaldehyde (sensitivity check)
Positive control results:
Clear positive results after challenge with 0.25% formaldehyde in distilled water.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No symptoms of systemic toxicity were observed in the animals during the study.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No symptoms of systemic toxicity were observed in the animals during the study.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .
Reading:
other: Controls
Group:
negative control
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
No symptoms of systemic toxicity were observed in the animals during the study.
Remarks on result:
other: Reading: other: Controls. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .

CONTROL GROUP:

Eight, one and one animal showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentration, respectively. These skin reactions were characterised by red spots, scaliness.

EXPERIMENTAL GROUP:

Sixteen, one and two animals showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentrations, respectively. These reactions were characterised by redness, crust, swelling and scaliness. Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, five animals showed a positive skin reaction in response to the 2% concentration.

No symptoms of systemic toxicity were observed in the animals during the study.

No mortality occurred during the study.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions used in this study, treatment with the substance resulted in a sensitisation rate of 25 per cent.

Applying the rating of allergenicity described by Kligman A.M. (1966) on the results obtained in this test, the substance is considered to have mild sensitising properties. However, it does not meet the criteria for classification (≥ 30 % responding at > 1 % intradermal induction dose ). See ECHA Guidance on the Application of the CLP Criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The substance does not need to be classified according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008.


Migrated from Short description of key information:
In a Guinea-Pig Maximization Test, the substance resulted in a sensitisation rate of 25 per cent. This does not meet the criteria for classification (≥ 30 % responding at > 1 % intradermal induction dose ). See ECHA Guidance on the Application of the CLP Criteria.

The substance is severely corrosive to the skin of rabbits, a factor that must be considered in interpretation of the study results. Tthe substance is not considered to be a sensitiser.

Justification for selection of skin sensitisation endpoint:
This study was carried out in accordance with the OECD Guideline No. 406,
*Skin Sensitisation*, the EEC Directive 84/449/EEC, Part 8.6, *Skin Sensitisation* and in accordance with the method described by Magnusson and Kligman, 'Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a Guinea-Pig Maximization Test, the substance resulted in a sensitisation rate of 25 per cent.

This does not meet the criteria for CLP classification (≥ 30 % responding at > 1 % intradermal induction dose ).