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EC number: 236-039-7 | CAS number: 13114-72-2
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Assessment from available information
- Adequacy of study:
- key study
- Study period:
- October-November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Version / remarks:
- Assessment of Toxicokinetic Behaviour
- Executive summary:
The test substance after single oral administration of high dose level invoked the toxic answer of organism: death of animals occurred.The test substance penetrated into organism after single oral application – the systemic toxicity was observed.
After acute dermal exposition, the local changes of test area were not recorded. No systemic toxicity was observed, so the substance probably did not enter the organism through the skin. Also the results of sensitisation study - negative sensitising response after topical application to the mouse ear in LLNA support this conclusion. No erythema and skin reaction, no clinical signs of intoxication of experimental animals were recorded.
After evaluation of theBovine Corneal Opacity and Permeability Test the test substance was not identified as a corrosive or severe irritant. This result was confirmed by examination of eye after single application of substance to the conjunctival sac of rabbit. The test substancewas not irritating to theeye of rabbit, no clinical signs of systemic intoxication were detected.
Akardit did not penetrate into the organism through the skin and eye tissues.
Repeated oral exposition of the substance resulted in entering into organism and its systemic distribution.After oral administration, the test substance caused systemic intoxication of organism. It is fairly quickly absorbed from digestive tract and systemically distributed through the body. Immediately after application of the test substance the following clinical symptoms were observed: poking the nose to the bedding, disquiet/ irritation, salivation, piloerection and hunched posture Also bizarre behaviour – auto-mutilation (injured tail, sore in skin on the neck), symptoms of stress (focal loss of fur, salivation, disquiet/ irritation) was observed randomly during the study. After the end of application of the test substance all clinical symptoms were observed sporadically. Complete disappear of clinical signs in animals was recorded at the end of the study.
The main target organ in organism is liver. Significantly increased weight of liver (dose dependent) in males and females were recorded. Changes related with the metabolism of the test substance were observed during the biochemical examination.
The test substance Akardit had negative effect on motility and morphology of sperms. The test substance probably penetrates into the testes.
With respect to the results of reproduction toxicity part of repeated study it is possible to confirm penetration through the placental barrier -abnormalpups were found out in all treated
No data about metabolism, distribution and excretion of the test substance were found.
Reference
Description of key information
Evaluation of toxicokinetics of the substance Akardit, was performed according to the demand given in part 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006 (REACH): “Assessment of the toxicokinetic behavior of the substance to the extent that could be derived from the relevant available information”.
Klimish score 1.
The main target organ in organism is liver. Significantly increased weight of liver (dose dependent) in males and females were recorded. Changes related with the metabolism of the test substance were observed during the biochemical examination.The test substance Akardit had negative effect on motility and morphology of sperms. The test substance probably penetrates into the testes.
With respect to the results of reproduction toxicity part of repeated study it is possible to confirm penetration through the placental barrier -abnormal pups were found out in all treated animals.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
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