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Description of key information

OECD 404: Skin irritation after 3 min, skin corrosion after 4 hour exposure.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of the test item (as cited by study report): 2-mercaptoethanol sodium
Species:
rabbit
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 1.05 mL
- Concentration: 45.21% (aueous solution)
Duration of treatment / exposure:
3 min
Observation period:
12 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: the flank

SCORING SYSTEM: Draize scale
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
<= 4
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: Crust formation no erythema scoring possible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Dryness of skin observed during the second and third day
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Dryness of the skin observed at day 7
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
One hour after removal of the patch after a 4 hour application to a single animal, signs of lesions through the whole depth of the skin were observed and the animal was sacrificed for humanitarian reasons. After a 3 minute exposure no ulceration or necrosis was seen.
Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance was tested according to OECD 404. 3 Rabbits were exposed to 1.05 mL test substance (45.21% aq. solution) for 3 minutes under semiocclusive conditions. Erythema was observed in 2/3 animals after 24, 48 and 72 hours (average score according to Draize of 2 for both animals) but reversible within 7 days. The erythema score of one animal could not be determined due to crust formation. In 3/3 animals edema was observed and was reversible within 3 days in 1 animals and within 7 days in the remaining 2 animals (average scores were 2, 2.66, and 4, respectively). A preliminary test was performed with the test substance with an exposure duration of 4 hours. 4 hours exposure to the test substance results in skin corrosion (ECETOC, 1995). Under the conditions of the test it was concluded that the substance is skin corrosive.

Fentem et al. (1998) tested the skin irritation potential of the test substance in four in four validated in vitro assays: The rat skin TER assay; CORROSITEX; the Skin ZK1350 corrosivity test; and EPISKIN test. The test substance showed to be corrosive in the TER and CORROSITEX assays and not corrosive in the Skin2 model and EPISKIN. The negative results can be explained the test substance is a reducing agent (Barratt et al., 1998) and able to cause a change in the colour of MTT, leading to false viability values.

Justification for classification or non-classification

Based on the available data, the substance is classified as Skin Corr. 1B (H314) and Eye Damage 1 (H318) according tot he EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.