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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
No data are available. 
Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
other justification
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Effects on fertility: via oral route

No data are available.

 

Effects on fertility: via inhalation route

In the available subchronic repeated dose toxicity study (The Dow Chemical Company, 1980) the test material was investigated for repeated dose toxicity via inhalation. The study predates the appropriate OECD test guideline and GLP, but was conducted in compliance with standards used in this laboratory at that time. However, the study was conducted comparable to the OECD test guideline 413. 20 Fischer 344 rats per sex per dose were treated with vapour of the test item in a whole-body inhalation system for 6 h/day and 5 days/week for 13 consecutive weeks at doses of 25, 80, and 250 ppb (equivalent to 1.583, 0.507, and 0.158 mg/m³), whereas control animals were treated with the vehicle only (air). At the end of the exposure period 10 animals per sex per dose were sacrificed. In order to assess the reversibility of treatment-related effects and to identify potential latent effects of exposure, the remaining 10 animals per sex per dose were maintained for further 30 and 90 days of observation, respectively. At gross pathology, accessory sex glands, epididymides, mammary tissue, ovary, oviduct, testes, and uterus were investigated for treatment related effects, whereas epididymides, mammary tissue, ovary, oviduct, and seminal vesicles of control and high dose animals, as well as all low and mid dose animals with grossly described lesions, were submitted to histopathological examination. In addition, tested were weighed. No treatment related effects were observed in any of the animals at any dose. Additionally, animals of the recovery groups did not show any delayed effect on the reproductive organs or tissues. Based on these findings, the NOEL for effects on reproductive organs and tissues was set at 250 ppb (equivalent to 1.583 mg/m³).

In accordance with Column 1 of REACH Annex IX, the 2-generation reproductive toxicity study (required in Section 8.7.3 of REACH Annex IX) does not need to be conducted as data from this inhalative 90-day study do not indicate adverse effects on reproductive organs or tissues of both males and females. Hence, classification for toxicity to reproduction (fertility) according to 67/584/EEC and EC/1272/2008 is therefore not warranted.

 

Effects on fertility: via dermal route

No data are available.


Effects on developmental toxicity

Description of key information
There are no data available on the developmental toxicity/teratogenicity of 2-isocyanatoethyl methacrylate.
In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmental toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

No data are available.

Justification for classification or non-classification

The available data are reliable and suitable for classification. Based on this data, classification for toxicity to reproduction according to 67/584/EEC and EC/1272/2008 is not warranted.