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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The test substance was considered sensitizing under the condition of the GPMT assay. In the study according to OECD guideline 406 with GLP10 guinea pigs (control n=5) received for induction intradermal injection of 5% (v/v) test substance solved in purified water and  FCA:physiological saline and topical application 50% (v/v) in purified water and  FCA:physiological saline. For challenge 25% (v/v) in purified water and  FCA:physiological saline was used. After challenge no dermal reactions were detected for all treated animals.

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study already available
Species:
guinea pig
Strain:
other: Ibm: GOHI; SPF-quality (Himalayan spotted).
Sex:
female
Details on test animals and environmental conditions:
Source RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
Age/weight at study initiation
Age at pretest start/beginning of acclimatization period: 4 - 6 weeks.
Body weight of pretest groups at start of pretest: 335 to 379 g.
Body weight of control and test group at beginning of acclimatization period: 356 to 410 g.
Route:
intradermal and epicutaneous
Vehicle:
other: Freund’s Adjuvant – Complete
Concentration / amount:
Intradermal induction: 5% in purified water and FCA:physiological saline. Epidermal induction: 50% in purified water.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% in purified water.
Day(s)/duration:
Day 22 (2 weeks after epidermal induction).
No. of animals per dose:
Intradermal Pretest: 1 female.
Epidermal Pretest: 2 females.
Control Group in Main Study: 5 females.
Test Group in Main Study: 10 females.
Details on study design:
Rechallenge: Not performed.
Scoring schedule: 24 and 48 h after challenge
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
Total no. in group:
5
Remarks on result:
other: result not stated
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: result not stated
Interpretation of results:
GHS criteria not met
Executive summary:

Ten female Himalayan spotted guinea pigs each received intradermal applications of 5% MERGAL V615 in both purified water and in a 1:1 (v/v) mixture of FCA: physiological saline, followed a week later by an epidermal application of 50% MERGAL V615 in purified water (occlusive) during the induction period. Two weeks after the epidermal induction, the animals received a topical application of the test article (25% in purified water), which was the previously determined maximum non-irritating concentration of the test article. Twenty-one hours after removal of the dressing, treated sites were depilated as described previously. Five guinea pigs served as controls that received the intradermal and epidermal inductions without the test agent. Two weeks after induction, the control animals received challenge applications of purified water and 25% MERGAL V615 in purified water. All animals were observed for erythema and oedema at 24 and 48 hours after removal of the occlusive dressings.

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

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on these data, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.