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Administrative data

Description of key information

No skin sensitizer (OECD 406, GLP)


Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.
The test material has been classified as a NON-SENSITISER to guinea pig skin.

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:
3 October-6 November 1994
Reliability:
1 (reliable without restriction)
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Method B6 of Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive
67/548/EEC)
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA or the MEST methods can be used as a first stage in the assessment of skin sensitisation potential. If a positive result is seen in either assay, a test substance may be designated as a potential sensitiser, and it may not benecessary to conduct a further guinea pig test. However, if a negative result is seen in the LLNA or MEST, a guinea pig test (preferably a GPMT or Buehler Test) must be conducted
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Age: approx. 8 to 12 weeks old
Body weight: 360 435 g
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's Complete Adjuvant and distilled water
Concentration / amount:
Induction of the Test Animals:
i ) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1.
i i ) a 20% w/ v dilution of test material in distilled water.
i i i ) a 20% w/ v dilution of test material in a preparation of Freund's Complete Adjuvant plus distilled water.
Day(s)/duration:
24h,48h
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's Complete Adjuvant and distilled water
Concentration / amount:
10, 20% v/ v in distilled water
Day(s)/duration:
24 h
No. of animals per dose:
Preliminary study: 4 females
Experimental group; 20 females
Control group: 10 females
Details on study design:
Main Study
a) Induction of the Test Animals:
i ) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1.
i i ) a 20% w/ v dilution of test material in distilled water.
i i i ) a 20% w/ v dilution of test material in a preparation of Freund's Complete Adjuvant plus distil led water.

Approximately 24 and 48 hours after intradermal injection the degree of erythema at the test material injection sites (i . e.
injection site i i ) was evaluated according to the scale shown in Appendix X.
One week l ater (Day 7) , the same area on the shoulder region used previously for intradermal injections was cl ipped again and treated with a topical appl ication of the test material formulation (20% v/ v in distilled water) . The test material formulation was appl ied to saturation on filter paper (WHATMAN No.4: approximate size 40 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 50 mm x 30 mm) and covered with an overl apping length of aluminium foil . The patch and foil were further secured by a strip of elastic adhesive bandage ( ELASTOPLAST : approximate size 250 mm x 35 mm) wound in a double layer around the torso of each animal . This occlusive dressing was kept in place for 48 hours.
The degree of erythema and oedema was quantified one and twentyfour hours following removal of the patches using the scale shown in Appendix X.
Any other reaction was also recorded.
Challenge controls:
Shortly before treatment on Day 21, an area, approximately 50 mm x 70 mm on both flanks of each animal , was clipped free of hair with veterinary cl ippers. A quantity of the test material formulation (20% v/ v in distilled water) was applied to saturation to the shorn right flank of each animal on a square of filter paper (WHATMAN No. 4: approximate size 20 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm) .
To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 10% v/ v in distilled water was also similarly applied to a separate skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 75 mm) wound in a double layer around the torso of each animal .
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
Positive control material: Alpha-Hexylcinnamaldehyde Tech. 85% Induction Intradermal: 25% in arachis oil Induction Topical: 100% and 75% in arachis oil
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
Positive control material: 2-Mercaptobenzothiazole Induction Intradermal: 10% in arachis oil Induction Topical: 50% and 95% in aqueous ethanol
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
Positive control material:Ethyl 4-aminobenzoate 98% Induction Intradermal: 3% in a 6% preparation of acetone in arachis oil Induction Topical: 25% and 80% in aqueous ethanol
No. with + reactions:
7
Total no. in group:
18
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
Positive control material: 2,4-Dinitrochlorobenzene Induction Intradermal: 0.1% in arachis oil Induction Topical: 0.1% and 0.05% in arachis oil
No. with + reactions:
9
Total no. in group:
9
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.
The test material has been classified as a NON-SENSITISER to guinea pig skin.
Executive summary:

Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.

The test material has been classified as a NON-SENSITISER to guinea pig skin.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No skin sensitizer (OECD 406, GLP)


Since no skin reactions were observed in the challenge, it can be concluded that no sensitisation reaction occurred.
The test material has been classified as a NON-SENSITISER to guinea pig skin.