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Description of key information

The oral and dermal LD50 values for both structural analoques were greater than 2000mg/kg.

There was no mortality after inhalation of a saturated atmosphere of CAS 27458 -92 -0 for 8h.

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:
See justification attached to IUCLID chapter 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 400 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See justification attached to IUCLID chapter 13.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 0.3 mg/L air
Exp. duration:
8 h
Remarks on result:
other: as determined from read-across, CAS 27458-92-0
Interpretation of results:
study cannot be used for classification
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
300 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See justification attached to IUCLID chapter 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 960 mg/kg bw
Remarks on result:
other: as determined from read-across CAS 27458-92-0
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 960 mg/kg bw

Additional information

ORAL TOXICITY

Oral acute toxicity in rats was determined for the two structural analogues, CAS numbers 27458 -92 -0 (BASFSE, 2002) and 10042-59 -8 (Monsanto Company, 1979).

 

A GLP-compliant acute oral toxicity study was performed with structural analogue CAS 27458-92-0. The test was executed according to OECD guideline 423 and was performed on male and female Wistar rats according to the acute toxic class method. The test substance, which was dissolved in olive oil Ph.Eur./DAB, was administered orally (gavage) in a dose of 2000 mg/kg. The observation period was 14 days. Clinical signs observed were piloerection after 5 hours of administration in the male rats. Body weights increased during the study period. No mortality occurred and during the macroscopic pathology no abnormalities were noted. The LD50 value for male/female was determined to be >2000 mg/kg bw.

 

Additionally, an acute oral toxicity study was performed with structural analogue CAS 10042 -59 -8. The methods used were comparable to current guideline requirements and scientifically valid (non-GLP). The test substance was administered orally to male and female Sprague-Dawley rats via an unspecified method in doses of 5010, 6310, 7940, 10000 mg/kg. The observation period was 14 days. Clinical signs that were observed include increasing weakness, ocular discharge, diarrhea and collapse. Weight loss occurred during the first 4 days in survivors. Gross pathology showed hemorrhagic lungs, liver discoloration, and acute gastrointestinal inflammation in the decedents. The LD50 for male/female was determined to be 5400.0 mg/kg bw.

INHALATION TOXICITY

An inhalation risk test was performed with structural analogue CAS 27458-92-0. The test was performed in principle as described in OECD test guideline 403, but it was conducted before the implementation of GLP and OECD Guidelines. Data is restricted to inhalation hazard test with in part limited reporting, although these tests are sufficient for a valid risk characterisation. In the test, 6 male and 6 female Wistar rats were exposed (nose/head only) to a saturated test substance atmosphere of 0.3 mg/L (nominal) for 8 h. The observation period lasted 7 days. No mortality or clinical signs were observed and no gross pathological findings were noted. The LC0 for male/female Wistar rats was determined to be > 0.3 mg/L.

 

DERMAL TOXICITY

Dermal acute toxicity in rats was determined for both structural analogues.

 

Acute dermal toxicity was determined for structural analogue CAS 27458 -92 -0, by a method closely akin to the one-day cuff method of Draize et al. (1944). In this method, groups of 4 male albino rabbits are exposed to the test substance. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days. No information on clinical signs was given. An LD50 value of 7.07 mL/kg bw (ca. 5960 mg/kg bw) was determined.

 

Also, an acute dermal toxicity was performed with structural analogue CAS 10042-59 -8, where a single dermal dose of 3160, 5010 and 7940 mg/kg bw was applied on the skin of male and female New Zealand Albino rabbits for 24 hours. One of the two high dose animals died on day 2. The observation period lasted 14 days. Clinical signs observed were increasing weakness, diarrhea and collapse. Also weight loss occurred in days 2 - 6. Gross pathlogy showed hemorrhagic areas of the lungs, liver and spleen discoloration, enlarged gall bladder, darkened kidneys, and gastrointestinal inflammation in the decendents. The LD50 for male and females was determined to be > 5010.0 mg/kg bw.

Justification for classification or non-classification

Based on the available information the substance does not need to be classified for acute oral, inhalation and dermal toxicity, as in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.