Registration Dossier
Registration Dossier
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EC number: 205-154-4 | CAS number: 134-72-5
Endpoint summary
Administrative data
Description of key information
Six repeated dose studies were performed with two different species (rat and mouse), two different exposure times (14 and 90-days) and two different oral exposure types (via diet and drinking water). It can be concluded that the rat is the most sensitive species. The major adverse effect observed is the loss of body weight (observed in 5 out of 6 studies).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 22 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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
Six repeated dose studies were performed with two different species (rat and mouse), two different exposure times (14 and 90 -days) and two different oral exposure types (via diet and drinking water). All these studies were presented in the same NTP report from 1986 and are performed to determine the doses suitable for the carcinogenicity studies presented in this dossier.
In the first study five Fischer 344/N rats per sex per dose were given drinking water containing 0, 75, 150, 300, 600, or 1200 ppm of the test substance. In the second study five B6C3F1 mice per sex per dose were given drinking water containing 0, 312.5, 625, 1250, 2500, or 5000 ppm of the test substance. In the third study five Fischer 344/N rats per sex per dose were fed diets containing 0, 90, 190, 380, 750, or 1500 ppm of the test substance. In the fourth study five B6C3F1 mice per sex per dose were fed diets containing 0, 300, 600, 1250, 2500, or 5000 ppm of the test substance. All of these animals were exposed on 14 consecutive days, observed twice per day and weighed on days 1 and 15. Animals exposed via drinking water were additionally weighed on day 7. After the exposure period all animals were necropsied and blood was taken for the determination of packed cell volume.
In the fifth study ten Fischer 344/N rats were given diets containing 0, 125, 250, 500, 1000, or 2000 ppm of the test substance. In the sixth study ten B6C3F1 mice per sex per dose given diets containing 0, 310, 630, 1250, 2500, or 5000 ppm of the test substance. All of these animals were exposed on a daily basis for 13 weeks, observed twice per day and weighed once per week. After an exposure period of 13 weeks, animals were necropsied, blood was taken for the determination of packed cell volume and pupil diameters were measured.
During the feed studies in general there was no difference in feed consumption between animals receiving control diets and those receiving diets containing the test substance. However, during the drinking water studies, mean water consumption by animals receiving the test substance at 600 ppm or above was reduced. No deaths attributable to compound-related toxicity occurred. Hyperactivity and excitability were the most frequent clinical observations and were observed with the greatest incidence in animals receiving 1000 ppm or more of the test substance. Compound-related reduced weight gain was observed in each sex of both species, while food consumption was not different amongst exposure groups. In the studies it is observed that the rat is more senstitive to the test substance than mice.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Six repeated dose studies are available. Three are performed with rats and three with mice. The most sensitive species and longest exposure time is chosen as key study.
Justification for classification or non-classification
Because the major adverse effect observed is the loss of body weight and there is no evidence of organ dysfunction, classification for specific target organ toxicity after repeared exposure is not warranted in accordance with Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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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