Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 April 2001 - 06 April 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17, 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)

EC Number:

629-704-1

Cas Number:

226995-92-2

Molecular formula:

The substance is a UVCB - no specific molecular weight or formula is available.

IUPAC Name:

Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)

Test material form:

liquid

Specific details on test material used for the study:

Storage: Room temperature and humidity

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Pre-test body weight range of the male rabbits was 2.2-2.5 kg.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours post-treatment.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: All animals

Time point:

24/48/72 h

Score:

1

Max. score:

1

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Erythma was absent to barely perceptible at 60 minutes following patch removal and absent at 24, 48 and 72 hours. Oedema was absent at all observation periods. There were no abnormal physical signs noted during the observation period. All body weight changes were as expected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not a dermal irritant.

Executive summary:

The irritant or corrosive effects of the substance when applied dermally was evaluated in three New Zealand White rabbits according to the OECD TG 404. Three healthy male rabbits were dosed dermally with the substance (0.5mL/animal) to one intact site/rabbit. The substance was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes following patch removal. Reactions were scored again at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Erythma was absent to barely perceptible at 60 minutes following patch removal and absent at 24, 48 and 72 hours. Oedema was absent at all observation periods. There were no abnormal physical signs noted during the observation period. All body weight changes were as expected. It is concluded that the substance is not a dermal irritant.