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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Read-across study
Justification for type of information:
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 2.0 - 3.8 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/patch
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hour exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system.1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks on result:
other: no irritation reactions

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the study results, the read-across analogue source substance sodium methyl cocoyl taurate (SMCT) is not irritating to rabbit skin.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is expected to be non-irritating to the skin.
Executive summary:

The primary skin irritation potential of sodium methyl cocoyl taurate (SMCT) was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL of undiluted test material.The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema and oedema were evaluated numerically according to the score of DRAIZE. Slight to well defined erythemas were observed in all animals shortly after removal of the plaster at the 30 - 60 minute reading. Only one animal showed a slight erythema 24 hours after exposure. Form the 48 h reading in this animals and from the 24 hour reading in the remaining 2 animals until the end of the study no signs of irritation were observed in any of the animals. The overall mean scores after 24, 48 and 72 hours were 0.1 for erythema and 0.0 for edema. Based on the study results, no skin irritating potential is attributable to SMCT in rabbits under the described test conditions.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is expected to be non-irritating to the skin.