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Description of key information

Results for acute oral toxicity were based on three substances which are constituents of the target substance and therefore show high structural similarity to the target substance (EC 943-133-8).

For CAS No. 85029-59-0, the LD50 for acute oral toxicity was determined to be 5500 mg/kg bw.

For CAS No. 85029-58-9, the LD50 for acute oral toxicity was determined to be > 5000 mg/kg bw.

For CAS No. 84961-40-0, the LD50 for acute oral toxicity was determined to be 1200.0 mg/kg bw.

According to CLP 3.1.3.6. Classification of mixtures based on ingredients of the mixture, the ATE of this mixture (UVCB) is 3333 mg/kg bw. The substance has not to be classified.

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:
key study
Justification for type of information:
Please refer to chapter 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
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: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 85029-58-9
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-59-0
Remarks:
Correction for molecular weight not necessary.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 333 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 substance-specific data on the acute oral toxicity of the substance (EC 943-133-8) are available. However, according to Article 13 of legislation EC1907/2006, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. CAS No. 85029-58-9, CAS No. 84961-40-0 and CAS No. 85029-59-0 are constituents of the test item with high structural similarity to the target substance EC 943-133-8. Therefore, the toxicological behavior of EC 943-133-8 is expected to be similar to that of CAS No. 85029-58-9, CAS No. 84961-40-0 and CAS No. 85029-59-0.

Acute toxicity: oral

CAS No. 85029-59-0

Gassner rats were exposed by oral gavage to theCAS No. 85029-59-0(5 animals/sex/dose) at dosages of 200, 2500, 3200, 4000, 5000, 6400, 8000 and 10000 mg/kg (BASF, 1981). Olive Oil was used as vehicle. Animals were subjected to clinical observation during a period of 7 days. Mortality was noted after 1 hour, 1 day, 2 days and 7 days.Immediately after application all treated animals showed chewing movements and after approximately 4 hours the animals crouched. From 4 days irregular breathing, orange colouring of the fur, eyes, ears, arms, legs, faeces and urine was observed. The animals from the 5000 and 6400 mg/kg group were without symptoms from day 7, the animals from the 2000 to 4000 mg/kg group were without symptoms from day 5. No mortality was observed up to 3200 mg/kg. In the 4000 and 5000 mg/kg group 1 male and 3 females respectively died within 7 days. In the 6400 mg/kg group all females and 4 males died within 7 days. In the 8000 and 10000 mg/kg groups all animals died within 7 days.All animals were subjected to pathological examination. Finding in animals that died during the study included acute dilution of both heart chambers; general congestion hyperaemia; thin, pulpy and red-brown/orange stained stomach contents; diarrheal reddish contents in the intestines (containing blood in one case); red/orange coloured musculature and adipose tissue, very thin appearance and bloody erosions in the glandular stomach area. In the sacrificed animals organs were slightly reddish coloured.Based on these data, an LD50 of 5500 mg/kg was determined for both males and females.

CAS No. 85029-58-9

In an acute oral toxicity study, Sprague-Dawley rats (5 per sex per group) were given a single dose of CAS No. 85029-58-9 in carboxymethyl cellulose (CMC) at a dose of 5000 mg/kg bw (BASF, 1974). Due to technical reasons, a higher test substance concentration (more than 16%) could not be applied. No mortality was observed within 7 days and the LD50 was determined to be > 5000 mg/kg bw.

 

CAS No. 84961-40-0

In a study equivalent to OECD Guideline 401, acute toxicity of CAS No. 84961-40-0 was tested using male and female Sprague-Dawley rats (BASF, 1972). 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. Animals were weight 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. The LD50 of males and females was determined to be 1400.0 mg/kg.

Justification for classification or non-classification

Based on the results of the available studies, the substance has not to be classified for acute oral toxicity, in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.

Results for acute oral toxicity were based on three substances which are constituents of the target substance and therefore show high structural similarity to the target substance (EC 943-133-8).

For CAS No. 85029-59-0, the LD50 for acute oral toxicity was determined to be 5500 mg/kg bw (C1=50%)

For CAS No. 85029-58-9, the LD50 for acute oral toxicity was determined to be > 5000 mg/kg bw (C2=25%)

For CAS No. 84961-40-0, the LD50 for acute oral toxicity was determined to be 1200.0 mg/kg bw (C3=25%)

100%/ATEmix = C1 / 5500 mg/kg bw + C2 / 5000 mg/kg bw + C3 / 1200 mg/kg bw

100%/ATEmix = 0.034921

ATEmix = 100 / 0.034921

ATEmix = 3333 mg/kg bw