Formaldehyde, reaction products with phenol heptyl derivs. and 1,3,4-thiadiazolidine-2,5-dithione

Endpoint summary

Description of key information

Skin: The neat (100%) test material induced moderate to severe erythema and slight to moderate oedema at 24 and 72 hour observations. Coriaceousness and a light brown discolouration was observed at the application site. There was no evidence of reversibility over the limited timeframe of the study.
Eye: The average irritation score was 5.0 at 1 hour, 16.5 at Day 1, 16.2 at Day 2, 12.5 at Day 3, 9.0 at Day 4 and 4.3 at Day 7. The overall Primary Ocular Irritation Index was 11.7. All six animals showed some degree of recovery by the end of the 7 -day examination period but the effects were not fully reversible in 7 days.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin

In a key study performed by a similar method to Federal Hazardous Substances Act (16 CFR 1500), two New Zealand White rabbits were shaved and a 0.5 mL portion of the test material was applied to an intact skin site. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 4 hours and washed .

Treated areas were examined for erythema and oedema using the Draize method of scoring at 24 and 72 hours.

The neat (100%) test material induced moderate to severe erythema and slight to moderate oedema at 24 and 72 hour observations. Coriaceousness and a light brown discolouration was observed at the application site.

There was no evidence of reversibility over the limited timeframe of the study.

In a supporting study also performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations, six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Well-defined erythema and slight oedema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined erythema and very slight oedema was observed at the intact and abraded sites of all animals was observed at all intact sites and abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance as Category 2 skin irritant is required for skin corrosion/irritation.

Eye

In the key eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act, 0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

No effects on the iris were observed in any animal at any observation period. The average irritation score was 5.0 at 1 hour, 16.5 at Day 1, 16.2 at Day 2, 12.5 at Day 3, 9.0 at Day 4 and 4.3 at Day 7. The overall Primary Ocular Irritation Index was 11.7. All six animals showed some degree of recovery by the end of the 7 -day examination period but the effects were not fully reversible in 7 days.

In a supporting eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,

0.1 mL of the test material was instilled into tone eye of two young adult albino rabbits. The test material was not washed from the eye. Treated eyes were examined at 24 and 72 hours following treatment. Interpretation of results was made in accordance with the Draize scale. (The animals treated were also used simultaneously for the determination of the skin irritation potential of the material; see Key skin irritation Kreuzmann 1990)

The eyes of both animals showed evidence of severe irritation (corrosion) at the 24 hours observation.

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance as Cat 1: Irreversible effects on the eye, is required for eye irritation.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance as Category 2 skin irritant is required for skin corrosion/irritation.

Eye

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance as Cat 1: Irreversible effects on the eye, is required for eye irritation.