5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride

Endpoint summary

Description of key information

Skin: not irritant

Eye: irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritation potential of the test substance was evaluated in an in vivo study in accordance with the OECD guideline No. 404.

The test substance was applied in six New Zealand White rabbits at the intact skin. The observation period was 24, 48 and 72 hours after the start of application. Irritation score was 0 for all rabbits.

In another study the skin irritation potential of the test substance was evaluated in an in vivo study in accordance with the OECD guideline No. 404 and the EU Method B.4.

The test substance was applied in three New Zealand White rabbits at the intact skin of the shaved area on one flank, using a Scotchpaknon-woven patch of 2x3. A similar patch (but without test substance and water) was applied to the controlateral flank, to act as a procedural control.

The sites were monitored for erythema and oedema according to Draize scale, at 1, 24, 48 and 72 hours after the removal of the dressing and test substance.

Four hours exposure to 0.5 g of test substance resulted in no skin irritation in the treated skin-areas of any of the three rabbits.

No signs of systemic intoxication were observed during the study period.

Dermal application of the test substance resulted in a primary irritation index of 0 (non irritating) when applied to the intact rabbit skin.

 

Eye irritation

The eye irritation potential was evaluated in an experimental study according to OECD 405 guideline.

The tes item was applied into the eye of six New Zealand White rabbits and the site was monitored for chemosis score, enanthema score, iris score and cornea opacity score and the site was monitored after application at 1h, 24h (day1), 48h, 72h and day 7.

The lesions observed at 72h showed a total reversibility in the 6 rabbits examined on day 7.

From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation.

 

The potential of the test substance to induce eye irritation has been evaluated in an vitro acute eye irritation/corrosion study in the rabbit.

The study was carried out in accordance with the OECD guideline No. 405 and the EU Method B.5.Instillation of a volume of approximately 0.1 ml of the test substance into an eye of each of three rabbits resulted in slight corneal injury in two animals, iridic irritation in one animal and irritation of the conjunctivae in all three animals. Corneal injury had resolved within 72 hours, the iridic irritation within 48 hours and the irritation of the conjunctivae had completely resolved within 14 days after instillation. No signs of systemic intoxication were observed during the study period.

Mean score (24/48/72 h) in all rabbits was < 1 for corneal opacity and iris. Effects on conjuctivae chemosis were scored < 2 in alll animals and effects for conjuctivae redness were scored ≥ 2 in 2/3 rabbits.

 

Justification for classification or non-classification

Skin irritation

According to the CLP Regulation (EC 1272/2008), classification as skin irritant (category 2) applies if the substance produces:
- mean value of ≥ 2.3 - ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
- inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
- in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

In available studies, no signs of irritation were seen, thus the test substance is not classified as a skin irritant.

 

Eye irritation

 According to the CLP Regulation (EC 1272/2008), classification as eye irritant (category 2) applies if the substance produces in at least 2/3 tested animals, a positive response of:

- corneal opacity ≥ 1 and/or iritis ≥ 1, and/or

- conjunctival redness ≥ 2 and/or

- conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

 

Based on experimental findings in the key study followed according OECD guideline No. 405 and the EU Method B.5, scores for effects observed are above the reference thresholds in at least 2/3 animals, thus the test substance is classified as an eye irritant category 2 (H319) within the CLP Regulation (EC) 1272/2008.

This is confermed by the other key study in which the results obtained under the experimental conditions showed that the application of the test article to the rabbit's eye provoked a slight irritation.