Registration Dossier

Administrative data

Description of key information

Skin
In vivo
Rabbit, 4 h: occlusive: irritating (Draize test; BASF AG 1982)
Rabbit, 4 h, semi-occlusive: not irritating (OECD 404; Hoechst 1986)
Eye
In vivo
Rabbit: irritating (Draize test; BASF AG 1982)
Rabbit: not irritating (OECD 405; Hoechst 1986)
Respiratory system
Actually, there is only limited information from repeated dose studies and an inhalation hazard test available.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of 2,6-xylidine

 

Skin

A Draize test was performed with six White Vienna rabbits (BASF AG, 1982). A 4-hour exposure to 0.5 g of the unchanged test substance produced reversible erythema and edema (overall erythema score of 1.61 and edema score of 1.41 for the readings 24, 48 h and 72 h) with superficial necrosis and desquamation present after 8 days of observation in all animals. Exposure for 1 hour under the same conditions also led to slight to moderate erythema and edema with scaling present on day 8 (end of observation period).

 

In a second report performed according to OECD 404, three rabbits were exposed to the unchanged test substance for 4 hours under semi-occlusive conditions (Hoechst 1986). Slight erythema was present in one animal which was fully reversible at least within 7 days, edema were not observed, while all other animals tested didn’t show any signs of irritation.

  

In summary, the tests performed on rabbit skin by the two laboratories indicate an irritant potential of the test substance which would require an adequate labelling according to the guidelines laid down by the EU or the GHS system.

 

Eye

An in vivo test comparable to OECD 405 was performed with three rabbits (BASF AG 1958). Eyes were left unwashed after application of the test substance and were observed for 8 days. The test substance caused reddening within 1 hour combined with enhanced secretion, corneal opacity and enhanced discharge. Pupils were found to be contracted in all animals within one hour after application and most symptoms were present throughout the first 72 hours after application. At the end of the study period (day 8) no irreversible signs of corneal damage were observed and most clinical symptoms returned to normal except slight redness in 2/3 animals.

  

 

Respiratory system

No valid data are available to judge the irritant capacity of the test substance on the respiratory tract. Due to the irritation of the respiratory tract/rhinitis observed in an IRT (BASF 1982) and the results of a long-term feeding study (by evaporation of the test substance) a classification with R37 has been proposed.


Effects on skin irritation/corrosion: slightly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin

Treatment of rabbits with 2,6-xylidine resulted in moderate skin irritation which was fully reversible within the observation period of 8 days. Regarding this, the test substance has to be classified as irritant according to criteria laid down by the EU and the GHS and labelled with R38 (EU) and Cat 2 (GHS). In addition the substance is listed in the CLP Regulation No 1272-2008 on classification, labelling and packaging of substances and mixtures and classifed as skin irritant (cat. 2).

 

Eye

Due to the reversible eye irritation effects, 2,6-xylidine has to be classified as eye irritant according to Cat. 2A according to GHS-criteria.

 

Respiratory system

Based on the results of the IRT and the long term feeding study, a classification as irritant to the respiratory tract which results in labelling with R37 is considered.