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)

Endpoint summary

Description of key information

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. 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.

In a reliable in vivo eye irritation study New Zealand White rabbits (n=6) were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The eyes were examined at1, 2 and 3 days post-administration of substance.Four of six eyes appeared normal at each observation period. Slight conjunctival irritation, noted in 2/6 eyes, cleared by day 2. There were no abnormal systemic observations.The substance is not an eye irritant under the conditions of this study.

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

Study period:

03 April 2001 - 06 April 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17, 1992

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Storage: Room temperature and humidity

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.

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 August 1997 - 21 August 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

other: FHSA 16 CFR 1500.42

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Stored at room temperature and humuidty.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The pre-test body weight range was 2.1 - 2.3 kg.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

A few seconds

Observation period (in vivo):

1, 2 and 3 days post-administration of substance.

Number of animals or in vitro replicates:

Six

Irritation parameter:

overall irritation score

Basis:

animal: 2 animals

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 2 days

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal: 2 eyes

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 2 days

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal: all 6 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal: all 6 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal: 4 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal: all 6 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Four of six eyes appeared normal at each observation period. Slight conjunctival irritation, noted in 2/6 eyes, cleared by day 2. There were no abnormal systemic observations.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not an ocular irritant.

Executive summary:

In an in vivo eye irritation study New Zealand White rabbits (n=6) were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The eyes were examined at 1, 2 and 3 days post-administration of substance. Four of six eyes appeared normal at each observation period. Slight conjunctival irritation, noted in 2/6 eyes, cleared by day 2. There were no abnormal systemic observations. The substance is not an eye irritant under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of a reliable in vivo skin irritation/corrosion study and an in vivo eye irritation study conducted on the substance, classification of the substance is not justified.