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Administrative data

Description of key information

Not skin irritant

Not 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/corrosion

Determination of the irritant and corrosive effects on skin of the test substance 3,4-Dichlorbenzotrichlorid was conducted in accordance with the OECD 404. After an acclimation period of at least 14 days, the animals were examined one day prior to the start of the study to establish that they were biologically normal. 6 New Zealand White adult albino rabbits were used in the study.

Approximately 24 hours before the test, fur was removed by clipping from the dorso-lateral area of the trunk (6 x6 cm) of each six rabbits. 500 µL of the test substance was applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed on the opposite dorso-lateral areas of the trunk of each animal and were loosely held in contact with the skin by means of a semiocclusive dressing for the duration of the exposure period. Thus, access by the animal to the patch and resultant ingestion/inhalation could be prevented. After 4 hours, the patches were removed, and the exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis. The contralateral skin area not treated served as control.

At the end of the study, dermal irritation was scored and recorded at 24, 48 and 72 h, 7 d and 14 d. According to the criteria set up in the CLP Regulation n. 1272/2008, no classification for skin irritation is applied. However, serious lesions and toxic effects other than dermal irritation were also recorded.

Eye irritation/corrosion

A study for irritant/corrosive potential on the rabbit's eye was conducted with 3,4 -Dichlorbenzotrichloride in accordance with OECD Guideline for Testing of Chemical n. 405. In respect to the OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the observed responses.

After an acclimation period of at least 14 days before the test start, an application volume of 100 µL test substance was instilled into the conjunctival sac of one ye of each of the three rabbits after gently pulling the lower lid away from the eyeball. the lids were gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test substance.The examinations of cornea iris and aqueous humour were facilitated by use of optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hrs after application of the test substance.. the eye was then rinsed with physiological NaCl solution in order to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of UV (area) and diffuse white illumination (intensity) according to McDonald and Shadduck, modified.

The test substance resulted to be not irritant to the rabbit's eye.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, a substance can be allocated in category 2 when (1) mean score of ≥ 2,3 and ≤ 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 (2) 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 reactions; or (3) 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 the available study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals, for both erythema/eschar and oedema reactions and signes of toxicity were fully reversible within 14 days. For this reason the test item is not classified for skin irritation/corrosion.

According to the CLP Regulation (EC 1272/2008), 3.3 Serious eye damage/eye irritation, a substance is allocated in category 2, eye irritation, when it produces in at least 2 of 3 tested animals a positive response of: (a) corneal opacity ≥ 1; and/or (b) iritis ≥ 1; and/or (c) conjunctival redness ≥ 2; and/or (d) conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of normally 21 days.

In the available study, the test substance did not induce any sign of toxicity after topic application and therefore it is not classified for eye irritation/corrosion.