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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A study on fertility (OECD 422, GLP) with wistar rats is currently ongoing.

This study is going to be considered to give sufficient information to permit the conclusion that the substance is not toxic to reproduction. For that reason no extended one-generation study is proposed.

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No studies on the test substance itself are available at the moment. An OECD 422 study is currently ongoing

According to item 8.7.2 in Column 1 of Annex IX of REACH (Regulation No 1907/2006), a 2-generation or extended one generation study is regarded a standard data requirement. In the ECHA Guidance on information requirements and chemical safety assessment; Chapter R.7a R7.6.6 a testing strategy for reproductive toxicity is described. It is stated that all substances needs to be subject to a thorough data review and that if sufficient data are available to permit a conclusion on reproductive and developmental toxicity potential, no further testing is required. This study is going to be considered to give sufficient information to permit the conclusion that the substance is not toxic to reproduction. Therefore, further testing for reproductive toxicity is considered not justified, taking into account animal welfare aspects.

Effects on developmental toxicity

Description of key information

No data on the test substance is available. Therefore data is derived from two structurally similar substances. For both substance a prenatal developmental toxicity study (OECD 414, GLP) is available in pregnant rats (Wistar and Sprague-Dawley) which were administered daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) at concentrations of 100, 300 and 1000 mg/kg bw. There was no evidence for toxicologically relevant adverse effects of the test substance on dams or pub development. The no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to chapter 13 for the category justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: No toxic effects at the highest dose tested
Remarks on result:
other: Read-across from CAS# 158318-67-3
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: overall effects
Remarks on result:
other: Read-across from CAS# 8013-07-8
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: Overall effects
Remarks on result:
other: Read-across from CAS# 8013-07-8
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No toxic effects at the highest dose tested
Remarks on result:
other: Read-across from CAS# 158318-67-3
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Developmental study (CAS 158318-67-3)

In a prenatal developmental toxicity study, in accordance with GLP and OECD 414, the test substance was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) to evaluate its potential maternal and prenatal developmental toxicity. Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance in the vehicle. Generally, clinical observations including water consumption, food consumption and body weight gain revealed no toxicologically relevant difference between the animals receiving 100, 300 or 1000 mg/kg bw/d and controls. Most of the females (18 out of 25) of the high-dose group (1000 mg/kg bw/d) and one female of the mid-dose group (300 mg/kg bw/d) showed transient salivation during the treatment period. Salivation occurred in the respective animals only within the 2-hour examination interval (i.e. < 2h after treatment). It is considered to be treatment-related, likely as a result of the bad taste of the test substance/vehicle preparation or due to local irritation of the upper digestive tract. It is not considered to be a sign of systemic toxicity. No differences of toxicological relevance between the control and the treated groups (100, 300 or 1000 mg/kg bw/d) were determined for any reproductive parameters, such as conception rate, mean number of corpora lutea, mean number of implantations, as well as pre- and postimplantation loss. Similarly, no influence of the test substance on fetal weight and sex distribution of the fetuses was noted at any dose. Overall, there was no evidence for toxicologically relevant adverse effects of the test substance on fetal morphology at any dose. Under the conditions of this prenatal developmental toxicity study, the oral administration to pregnant Wistar rats from implantation to one day prior to the expected day of parturition (GD 6-19) at doses as high as 1000 mg/kg bw/d caused neither evidence of maternal nor developmental toxicity. In conclusion, the no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d (BASF 2016)

Developmental study (CAS 8013-07-8)

The objective of the prenatal developmental toxicity study (OECD 414, GLP) was to evaluate the potential toxic effects of the test substance on the embryonic and fetal development when

administered daily by oral route (gavage) to pregnant female Sprague-Dawley rats during organogenesis (day 6 to day 15 of pregnancy inclusive).

Three groups of 25 mated female rats received daily by gavage the test substance at the dose levels of 100, 300 and 1000 mg/kg bw/day, from day 6 to day 15 of pregnancy inclusive. Simultaneously, a group of 25 mated females was given the vehicle Soybean oil (SBO) and acted as a control group. The day of mating was designated as day 0 of pregnancy. No clinical signs, no deaths and no abortions were noted in any of the groups. The mean food consumption and body weight gain of the females with completed pregnancy were similar in the control and treated groups. No treatment-related macroscopic changes were observed at necropsy of the females. The mean number of corpora lutea, implantation sites, live fetuses, the post-implantation loss and fetal body weight were similar in the control and treated groups. No extemal malformations were observed in fetuses of the control or treated groups. No treatment-related soft tissue anomalies or malformations were noted in fetuses of any group. No dose-related effects were noted on the incidence of the skeletal variations, anomalies or malformations.

In concusion, the test substance when administered daily by oral route (gavage) to pregnant female Sprague-Dawley rats during organogenesis at the dose levels of 100, 300 and 1000 mg/kg bw/day was well tolerated by the dams at all the dose levels and was neither embryotoxic or teratogenic (ETTEC 1993).

Justification for classification or non-classification

The available developmental toxicity studies from structural similar substances are reliable and suitable for classification purposes under Regulation 1272/2008. No adverse effects on fertility or development were observed. As a result, the substance is not considered to be classified for developmental toxicity under Regulation (EC) No. 1272/2008,as amended for the fourteenth time in Regulation (EC) No. 2020/217.

 

Additional information