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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports

Data source

Reference
Reference Type:
secondary source
Title:
HEALTH AND SAFETY STUDIES WITH ROBUST SUMMARIES FOR CAS 137-20-2
Author:
NTRL Report - submitted by Clairant Corp.
Year:
2006
Bibliographic source:
EPA-HQ-OPPT-2005-0055, NTRL Report - submitted by Clairant Corp., last updated 2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 406
Principles of method if other than guideline:
An irritation screening test was performed in Himalayan spotted guinea pigs to determine the irritation concentration of Sodium 2-(methyloleoylamino)ethane-1-sulphonate prior to sensitization study according to OECD 406 Guidelines
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-[methyloleoylamino]ethane-1-sulphonate
EC Number:
205-285-7
EC Name:
Sodium 2-[methyloleoylamino]ethane-1-sulphonate
Cas Number:
137-20-2
Molecular formula:
C21H40NO4S.Na
IUPAC Name:
Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Test material form:
solid
Details on test material:
Name of the test chemical: Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Molecular Formula: C21H40NO4S.Na
Molecular Weight: 425.606 g/mol
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Molecular Formula: C21H40NO4S.Na
Molecular Weight: 425.606 g/mol
Substance Type: Organic
Physical State: Solid
Batch Number: DEBD 007534
Concentration: 60-65%
Stability of the test item: stable under storage conditions
Expiry date: April 2005
Storage conditions: At room temperature 20 ± 3°C, protected from sunlight

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: Females
- Source: RCC Laboratory Services, Switzerland
- Age at study initiation: 4-6 weeks
- Weight at study initiation:339-369 g
- Fasting period before study: no data
- Housing: individually housed in Macrolon cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kilba guinea pig breeding/maintenance diet, containing Vitamin C, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: one day. Only animals without any visible signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): air conditioned with room temperature around 20 ± 3°C
- Humidity (%):30-70%
- Air changes (per hr): approximately 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): the animals were provided with automatically controlled light cycle of 12 hours light and 12 hours dark.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: PEG 500
Controls:
not specified
Amount / concentration applied:
0.5 ml of 4 different concentrations of test chemical 10%,15%,25%,50% (w/v)
Duration of treatment / exposure:
6 hours
Observation period:
24 and 48 hours after removal of patches
Number of animals:
4 females
Details on study design:
TEST SITE
- Area of exposure: four different sites on the trunk of the animal
- % coverage: 25mm Hill Top Chamber
- Type of wrap if used: elastic plaster wrapped around the trunk and secured with an impervious adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done):no
- Time after start of exposure: no data
SCORING SYSTEM: The visual scoring system for erythema and edema were assessed as follows:
0 = no visible changes
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema
The grading was performed 24 hours after patch removal and repeated 24 hours later(48 hour grades)

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or edema was observed.
Other effects:
No symptoms of systemic toxicity were observed in the animals. No changes in body weights were observed.

Any other information on results incl. tables

Table 1: Skin reactions during the irritation screen test

Animal number

Sex

Concentrations

Skin reactions after

24 hours

48 hours

801

Female

A=50%

0

0

B=25%

0

0

C=15%

0

0

D=10%

0

0

802

Female

A=50%

0

0

B=25%

0

0

C=15%

0

0

D=10%

0

0

803

Female

A=50%

0

0

B=25%

0

0

C=15%

0

0

D=10%

0

0

804

Female

A=50%

0

0

B=25%

0

0

C=15%

0

0

D=10%

0

0

 

3 hours prior to 24-hour reading both the flanks were depilated

Table 2: Body weights summary

Acclimatization

 

Group 1

Irritation screen

Day 1

Week 1

Mean

356 gm

Standard deviation

13.5gm

Minimum

339 gm

Maximum

369 gm

N

4

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The mean erythema and edema scores after 24 and 48 hours of patch removal were 0.0 for all the tested concentrations.
Hence, Sodium 2-(methyloleoylamino)ethane-1-sulphonate can be considered to be not irritating to the skin of female Himalayan spotted guinea pigs.
Executive summary:

An irritation screening test was performed in Himalayan spotted guinea pigs to determine the irritation concentration of Sodium 2-(methyloleoylamino)ethane-1-sulphonate prior to sensitization study according to OECD 406 Guidelines. 4 female Himalayan spotted guinea pigs were used for the study.0.5 ml of four different concentrations of test chemical dissolved in vehicle [PEG300] i.e 10,15,25 and 50% [w/v] were placed in 25mm Hill Top Chamber at 4 different sites on the trunk of the guinea pigs. The Hill Top Chamber was firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with an impervious adhesive tape. The occlusive dressing was left in place for 6 hours. 3 hours prior to 24-hour reading both the flanks were depilated. The grading for erythema and edema was performed 24 hours after patch removal and repeated 24 hours later(48 hour grades). The test animals were also observed for changes in body weights, clinical signs. No symptoms of systemic toxicity were observed in the animals. No changes in body weights were observed.The mean erythema and edema scores after 24 and 48 hours of patch removal were 0.0 for all the tested concentrations.

Hence, Sodium 2-(methyloleoylamino)ethane-1-sulphonate can be considered to be not irritating to the skin of female Himalayan spotted guinea pigs.

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