Registration Dossier
Registration Dossier
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EC number: 220-395-5 | CAS number: 2752-17-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Screening study: In accordance with Column 2 of REACH Annex VIII section 8.7.1, a screening for reproductive/development toxicity study does not need to be conducted, if a prenatal developmental toxicity study (Annex IX, section 8.7.2) is available. In addition, no significant effects on reproductive organs were observed in a 90 -day repeated dose toxicity study via the dermal route.
Extended one-generation reproductive toxicity study: In accordance with
column 1 of REACH Annex IX, an extended one-generation reproductive
toxicity study (required in Section 8.7.3) needs to be conducted if the
28-day or 90-day study indicates adverse effects on reproductive organs
or tissues. No significant effects on reproductive organs were observed
in a 90-day repeated dose toxicity study via the dermal route. In
addition, no significant treatment-related effects were seen in any
reproductive organs in either male or female Sprague-Dawley rats at any
dose level in a 14-week vapor inhalation study.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In accordance with column 1 of REACH Annex IX, a 2-generation reproductive toxicity test (required in Section 8.7.3) needs to be conducted if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. No significant effects on reproductive organs were observed in a 90-day repeated dose toxicity study via the dermal route.
In a 90-day dermal repeated dose study with the read-across substance BDMAEE in NZW rabbits conducted equivalent to OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study), no treatment-related effects were seen in any reproductive organs in either males or females at any dose level (i.e., 0%, 0.2%, 0.7% or 2% [0, 0.74, 2.8 or 8 mg/kg/day, respectively]).
In a 14-week vapor inhalation study in Sprague-Dawley rats with the read-across substance BDMAEE, no significant treatment-related effects were seen in any reproductive organs in either males or females at any dose level (i.e., 0, 0.23, 1.25, or 5.8 ppm [0, 1.51, 8.2, or 38.0 mg/m3, respectively]). Exposure-related increases in relative organ weights were observed for the adrenals and testes of males from the 5.8 ppm group at the 14-week time point, but not after the 6-week recovery period and these organs showed no histologic abnormalities.
Effects on developmental toxicity
Description of key information
A screening for reproductive/development toxicity study in accordance with Column 1 of REACH Annex VIII section 8.7.1 was waived because a pre-natal toxicity study (Annex IX, section 8.7.2) is available. In addition, no significant effects on reproductive organs were observed in a 90-day repeated dose toxicity study via the dermal route.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 3.37 mg/kg bw/day
- Species:
- rabbit
Additional information
Administration of the read-across substance BDMAEE by dermal application to timed-pregnant New Zealand white rabbits during organogenesis (gestation days 6-18) resulted in maternal toxicity at 10 % and 5 %, i.e., transient reduced weight gain during exposure at 10%, renal lesions at 5 and 10 % and elevated relative kidney weight at 10 %. There was no maternal toxicity at 1 % except for transient irritation at the application site. Toxicity to the fetus (reduced fetal body weight per litter) was observed unaccompanied by any indication of reduced fetal ossification, only at 10%, a dose which also produced signs of maternal toxicity. There was no evidence for embryotoxicity or teratogenicity at any dose level employed.
Justification for classification or non-classification
Based on the results of the pre-natal toxicity study with the read-across substance BDMAEE, BAEE does not meet the criteria for classification as reproductive or developmental toxicant according to EU Directive 67/548/EEC and Regulation 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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