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Administrative data

Description of key information

Acute oral toxicity study (equivalent to OECD 401) with the constituent CAS 84961-40-0: LD50 1200.0 mg/kg bw. The effect level is not corrected for the relative composition as a conservative approach.

Acute oral toxicity study (equivalent to OECD 401) with the constituent CAS 85029-57-8: LD50 > 10000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Please refer to the attached document for the read-across justification
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on read-across from CAS 84961-40-0
Remarks:
No correction for the relative composition is applied on the effect level as a conservative approach.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on read-across from CAS 84961-40-0
Remarks:
No correction for the relative composition is applied on the effect level as a conservative approach.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on read-across from CAS 84961-40-0
Remarks:
No correction for the relative composition is applied on the effect level as a conservative approach.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on read-across from CAS 85029-57-8
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 200 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No acute oral toxicity data is available on the substance itself. Therefore read-across is performed to the constituents with CAS 84961-40-0 and CAS 85029-57-8. No correction for the relative composition is applied on the effect level as a conservative approach.

CAS No. 84961-40-0

In a study equivalent to OECD Guideline 401, the acute toxicity of CAS No. 84961-40-0 was tested using male and female Sprague-Dawley rats. 5 animals/sex/dose were exposed to a single dose of 825, 1210, 1780, 2610 (only 4 males/dose) or 3830 mg/kg of test substance. Carboxymethyl cellulose (CMC) was used as vehicle. Animals were subjected to clinical observation during a period of 14 days. Clinical signs or mortality was noted at <15 min, 15 min, 30 min, 1 hour, 4 hours, 1 day, 2 days, 5 days, 6 days, 7 days, 8 days, 9 days, 12 days, 13 days and 14 days following exposure. Body weight was determined at 2-4, 7 and 13 days. All animals were subjected to pathological examination. No treatment-related effects were observed in the body weight changes. Diarrhoea and orange coloured faeces and/or urine was observed in all treated animals. Additionally, dyspnoea, apathy, stagger and a worse general condition was observed in the 2610 mg/kg dose group. No mortality was observed in the 825 mg/kg group. In the 1210 mg/kg group, 3 males and 3 females died after 7 days. In the 1780 mg/kg dose group, 1 male and 4 females died after 7 days. In the 2610 and 3830 mg/kg dose groups, all animals died after 7 days. Gross pathology only revealed findings in the animals that died during the study, which included acute dilation of the atria, acute hyperaemia and staining of the substance on organs/adipose tissue/musculature. Based on these data, an LD50 of 1600.0 and 1200.0 mg/kg was determined for males and females, respectively (BASF 1981).

CAS No. 85029-57-8

In a study equivalent to OECD Guideline 401, the acute toxicity of CAS No. 85029-57-8 was tested using male and female Gassner rats. 5 animals/sex/dose were exposed to a single dose of 8000 and 10000 mg/kg bw test substance. Carboxymethyl cellulose (CMC) was used as vehicle and the substance was administered as a watery 30% suspension. Animals were observed during a period of 14 days after 1 hour, 24 hours, 48 hours, 7 days and 14 days and necropsy of survivors was performed. No mortality was observed. Fast breathing during the first 3 hours after application. Necropsy revealed mild red staining of organs in both dose groups and 3 or 2 animals (in the 8000 and 1000 mg/kg bw dose group, respectively) had a parasite infection of the caecum (Oxyuren). Based on these data the LD50 was determined to be above 10000 mg/kg bw (BASF 1972). 

Justification for classification or non-classification

Based on the results of the available studies, the substance has to be classified as Acute Tox. 4, H302 (Harmful if swallowed), in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.