Sodium 2-[(1-oxododecyl)amino]ethanesulphonate

Skin irritation / corrosion

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

Test material information

Constituent 1

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.