Registration Dossier

Administrative data

Description of key information

The following available information was available for the irritation/corrosion endpoint:
Skin irritation/corrosion:
Dean, W. P. and Leong, B. K. J. (1977). Acute toxicity study in Rabbits and Rats. Report no.: 163-499. Report date: 1977-12-07.
Eye irritation/corrosion:
Dean, W. P. and Leong, B. K. J. (1977). Acute toxicity study in Rabbits and Rats. Report no.: 163-499. Report date: 1977-12-07.
Dean and Leong (1977) was selected as the key study for both exposure routes based upon the depth of reporting of the methodologies and results and the reliability score of 2 (according to the criteria of Klimisch et al, 1997). Additional information is available, however this information is included as supporting information only as the reliability assessment and depth of reporting indicate the the additional studies are less reliable that the key study.

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)

Additional information

Dean and Leong (1977) was selected as the key study for both exposure routes. Testing of the different exposure routes was carried out with separate test animals and with different test methodologies.

Skin irritation

In the key study the test substance was applied to 6 rabbits with intact (3 animals) and abraded skin (3 animals). The test substance was removed after 4 hours and the sites washed with tepid water. Skin irritation was assessed 1, 24, 48 and 72 hours following removal of the test substance. The reported results for animals with intact skin were, erythema 0.33 mean (0.5 maximum) at 24 hours and 0.16 mean (0.5 maximum) at 48 hours, all erythema was fully reversed at the 72 hour observation period. No edema was reported at any observation period during the study. These results were supported by Lewis and Palanker (1978) and Monma et al. (1984) which all reported primary dermal irritation index scores of 0 at the 72 hour observation period.

Eye irritation

In the key study, the test substance was placed into the cupped conjunctival sac of the right eye of 3 rabbits following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a wash out. The treated eyes were examined for irritation 24, 48, 72 hours and 7 days following application of the test substance. The results of the key study are:

conjunctivae score (Redness) mean 24 hours 0 0 fully reversible within: 7 days
mean 48 hours 0.2 0.5
mean 72 hours 0.3 1
chemosis score mean 24 hours 0 0 fully reversible within: 7 days
mean 48 hours 0.1 0.5
mean 72 hours 0.1 0.5
conjunctivae score (Discharge) mean 24 hours 0.3 1 fully reversible within: 7 days
mean 48 hours 0.2 0.5
mean 72 hours 0.1 0.5

These results are supported by Crown (1984), who reported results of <0.5 mean (1 max) for all effects and recorded a complete reversion of effects at the 73 hour observation time, and Lewis and Palanker (1978) who reported maximum results of 2 for conjuctivae redness and chemosis at 24 hours and 1 for conjuctivae redness and chemosis and discharge at 48 hours; all results were fully reversed at the 4 day observation time.

Justification for classification or non-classification

HBCDD is not a skin or eye irritant and does not meet the criteria for classification according to 67/548/EEC and EC Regulation 1272/2008.