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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The quality of the database was very low, with only one document was available for which the original language was Russian.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral toxicity

Sapegin (1985) conducted a 45 days subacute study on 128 white rats from both genders. Three doses were chosen to conduct the experiment (80, 160 and 800 mg/Kg bw/day). The test animals were examined before the beginning of the experiment, then on day 10, 20, 30 and 45. Symptoms included: Hematuria, decrease of the hemoglobin content and of the erythrocytes, lethargy, cyanosis, hair fall, dystrophic changes and patchy hemorrhages in myocardium, liver, kidneys, brain and spleen. The reported NOEL is 80 mg/Kg bw per day. The aim of the experiment was studying cumulative properties of the substance and selecting the method for chronic study.

A subchronic study was also carried out by Sapegin (1985) on 180 white rats (120 females and 60 males) over 6 months. The test item in a solution within an oil vehicle was administered 5 time per week to the testing animals. Three doses were chosen to conduct the experiment (0.4, 4 and 40 mg/Kg bw/day) over 6 months. Symptoms included: Increase of combinations necessary for the development of conditioned reflexes, increase of relative mass of brain and decrease of relative mass of liver, decrease of oxygen intake, increased content of met-hemoglobin in blood.The reported NOEL is 0.4 mg/Kg bw per day.

The available studies were disregarded as they were not conducted according to international guidelines, nor under a recognised quality assurance system. Furthermore, the method descriptions lack key details regarding the testing conditions (test material purity/impurities, no information on vehicle identity or purity, no information on housing and handling of the test animals) and the number of test animals used was non-standard.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The available studies were disregarded as they were not conducted according to international guidelines, nor under a recognised quality assurance system. Furthermore, the method descriptions lack key details regarding the testing conditions (test material purity/impurities, no information on vehicle identity or purity, no information on housing and handling of the test animals) and the number of test animals used was non-standard.

Justification for classification or non-classification

The available data is not considered to be reliable, or adequate for classification purposes.

The classification for this endpoint is inconclusive.

Harmonised classification

The above classification is overwritten by the group entry classification for chloroanilines according to Table 3.1 to Annex VI of CLP Regulation (EC) No 1272/2008. The legally-binding classification is the following: STOTRE Category 2 (minimum classification).

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