3,5-dichlorobenzoyl chloride

Endpoint summary

Description of key information

Skin

Corrosive, Category 1A, OECD 431 & EU Method B.40, in vitro three dimensional epidermal model (EpiDerm (EPI-200)), Eurlings (2015)

Eye

Not irritating, similar to OECD 405, rabbit, Powers (1969)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

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

This endpoint has been addressed with two studies, one key and one supporting.

The key study (Eurlings, 2015) has been assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

The potential of the test material to cause skin corrosion was investigated using the in vitro skin corrosion test with a human skin model in accordance with the standardised guidelines OECD 431 and EU Method B.40 bis under GLP conditions.

The assay investigates the ability of the test material to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of the test material was tested through topical application for 3 minutes and 1 hour and assessing the viability of the tissue. The test material was applied undiluted (50 μL) directly on top of the skin tissue. Milli-Q water and 8 N potassium hydroxide served as the negative and positive controls, respectively.

The positive control had a mean relative tissue viability of 8 % after 3 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range at the 1 hour treatment and just above the laboratory historical control data range at the 3 minute treatment. The acceptability criteria for the maximum inter-tissue variability in viability between two tissues treated identically and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues were met for the negative and positive control, indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test material. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test material compared to the negative control tissues was 29 and 32 %, respectively. As the mean relative tissue viability for the test material was below 50 % after the 3-minute treatment, the test material is considered to be corrosive.

Under the conditions of this study, the test material is corrosive in the in vitro skin corrosion test.

The supporting study (Powers, 1969) has been assigned a reliability score of 3 in line with the principles for assessing data quality as defined by Klimisch et al. (1997) as there is limited information on materials and methods presented. Moreover, there is incomplete reporting on results.

The test material has been classified as moderately irritating according to the Primary Irritation Index, based on the Draize Scale, 1959.

Eye Irritiation

This endpoint has been addressed with two one key study (Powers, 1969) which has been assigned a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

The potential of the test material to cause eye irritation in the New Zealand White rabbit was investigated in a study which was conducted using methodology broadly equivalent to the standardised guideline OECD 405.

A single application of 0.1 mL was made into the conjunctival sac of the left eye of nine rabbits. Three eyes were irrigated with 20 mL of tap water two seconds after application, three eyes were irrigated four seconds after application, and three eyes were not irrigated but were held closed for one second. Untreated right eyes served as controls.

Observations for gross signs of eye irritation and systemic toxicity were made at 24, 48, and 72 hours and 4, 7, 10, and 14 days following application. Eye irritation was graded and scored according to the Draize scale.

Blinking and preening of the treated eye was noted immediately following instillation.

-Irrigated Groups: From 24 hours, irritation included slight to marked (one eye) conjunctival erythema (subsiding by day 10), slight chemosis and discharge (subsiding by 72 hours or in one eye by day 7), and slight iritis (at 24 hours).

-Non-irrigated Group: From 24 hours, irritation included slight to moderate conjunctival erythema (subsiding by day 14), slight chemosis (subsiding by day 10), slight to moderate discharge (subsiding by day 10), slight iritis (subsiding by day 4), and in one eye slight corneal opacity at 24 hours. On day 10 and day 14, alopecia surrounding the eye was observed in two animals.

Terminal fluorescein examination confirmed the absence of corneal damage in all treated eyes.

Under the conditions of this study, the test material caused some eye irritation with no sign of toxic effects. All symptoms were fully recovered by the end of the observation period.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to skin irritation/corrosion as Category 1A: Corrosive (H314; Causes severe skin burns and eye damage). Accordingly, the substance also requires classification with respect to serious eye damage/eye irritation as Category 1: Irreversible effects on the eye (H318; Causes serious eye damage).