Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Endpoint summary

Description of key information

The submission substance produced slight skin and eye irritation in reliable in vivo studies, not severe enough to require classification.

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Origin: HOECHST AG, Kastengrund, conventional breed
Body weights: 3.4 - 3.9 kg
Age: approx. 3-5 months

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml of pure substance

Duration of treatment / exposure:

4 hours

Observation period:

The animals were assessed at 30 min, 60 min, 24 h, 48 h and 72 h after exposure.

Number of animals:

3

Details on study design:

Approximately 24 h before test start, the three test animals were clipped in an area of 25 cm² in the dorsal region with an electric clipper. Only animals with intact skin were used for the test. Each animal was treated with 0.5 ml pure test substance on the prepared skin area which was then covered with a 2.5 x 2.5 cm gauze patch then. The test site was then covered with a semi-occlusive dressing. The exposure time was 4 hours. After exposure, the patch was removed and the treated area washed with lukewarm water to remove the test substance from the skin. The treated skin was examined 30 min, 60 min, 24 h, 48 h and 72 h after removal of the patch for erythema, oedema or incrustation of the skin and scored, respectively.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

0.3

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Very slight erythema and oedema were observed 1 and 24 h after removal of the patch. However, these observations were reversible 48 h after removal of the patch.

Interpretation of results:

other: not irritant to skin

Conclusions:

The test substance is not irritating to skin.

Executive summary:

The skin irritation / corrosion properties of the test substance was assessed in an in vivo skin irritation study with rabbits. As a result of the study, the test substance is not irritating to skin.

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Origin: HOECHST AG, Kastengrund, conventional breed
Body weights: 3.5 - 4.0 kg
Age: approx. 3 - 5 months

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml per eye

Duration of treatment / exposure:

24 h

Observation period (in vivo):

The eyes were examined at 1h, 24 h, 48 h and 72 h after application of the test substance.

Number of animals or in vitro replicates:

3 animals

Details on study design:

Approximately 24 h before study start the eyes intended for treatment with the test substance were assessed after application of one drop of a 0.01 % sodium fluoresceine solution into the eye under UV light for damages of the cornea. Only animals with eyes without damages of the cornea were used for the study.
Each of the 3 animals was treated on the left eye's conjunctivae with 0.1 ml of test substance. The untreated right eye was used as control. The treated eyes were rinsed thoroughly with physiological saline solution (at 37 °C) 24 h after the application of the test substance and at each timepoint when the treated eyes showed secretion or when the cornea was assessed with sodium fluoresceine solution.
The treated eyes were assessed 1 h, 24 h, 48 h and 72 h after application of the test substance. At the 24 h and 72 h assessments, the cornea was assessed for damages as well after instillation of 0.01 % sodium fluoresceine solution under UV light. Damages to the cornea, iris and conjunctiva was assessed and scored numerically..

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

After 1 hour of the test substance application, the conjunctivae of the animals were coloured diffuse karmesin red to strong red and slightly swollen. In addition, clear and colorless secretion occurred. After one day after application, clear hyperemia of the conjunctivae blood vessels were observed. However, on day 2 after application of the test substance, all irritation signs were reversible.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not eye-irritating.

Executive summary:

The eye irritation potential of the test substance was assessed in a study according to OECD guideline 405 in rabbits. As a result of the study, the substance showed to be not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the skin irritation study, very slight erythema and oedema were observed 1 and 24 h after removal of the patch. However, these observations were reversible 48 h after removal of the patch.

In the eye irritation study, the conjunctivae of the animals were coloured diffuse karmesin red to strong red and slightly swollen 1 h after application. In addition, clear and colorless secretion occurred. After one day after application, clear hyperemia of the conjunctivae blood vessels were observed. However, on day 2 after application of the test substance, all irritation signs were reversible and scores were below the critical values for classification.

Justification for classification or non-classification

Slight skin and eye irritation was observed, not severe enough to require classification according to Regulation (EC) No. 1272/2008 (CLP).