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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex to Commission Directive 2004/73/EC (Official Journal No. L152, 30.4.2004). Part B, Method B.4 Acute Toxicity: Dermal irritation/corrosion. OECD Guideline for Testing of Chemicals No.404 “Acute Dermal Irritation/Corrosion”. Adopted 24 April 2002. EPA
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped
Vehicle:
other: The test substance was applied undiluted.
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
A single animal (number 25 F) received three exposures of three minutes, one or four hours duration in a step-wise manner and acted as a preliminary screen.In the absence of a severe effect on removal of the dressings the next exposure was initiated.
For exposures of one hour or more each treatment site was covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period. The animals were returned to their cages immediately after treatment.
At the end of the exposure period the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Observation period:
Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hr
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hr
Score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hr
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hr
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hr
Score:
0

Applicant's summary and conclusion

Conclusions:
The Primary Irritation Index was calculated to be 1.9; M3MC-Carboxylate was classified as ‘mildly-irritant’ according to the criteria of the ECETOC and required labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC.
Executive summary:

The Primary Irritation Index was calculated to be 1.9; M3MC-Carboxylate was classified as ‘mildly-irritant’ according to the criteria of the ECETOC and required labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC.