Registration Dossier

Diss Factsheets

Administrative data

Description of key information

LD50 oral: > 2000 mg/kg bw.
LD50 dermal: > 2000 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:
experimental study
Adequacy of study:
key study
Study period:
December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
A group of ten rats (5 males and 5 females) was treated at 2000 mg/kg bw. Animals were examined for mortality, clinical signs, body weight and a terminal autopsy was conducted.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
20% w/v in corn oil
10.0 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats.
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Piloerection was observed in all animals during day one only. There were no other clinical sings.
Body weight:
Slightly low body weight gains were reported for 4 male rats on day 8. All other rats achived anticipated body weight gains throughout the study.
Gross pathology:
Effects on organs: None
Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 rat > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Sprague-Dawley rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical sign piloerection was observed on the day of treatment only.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and has Klimisch score 1.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August-September 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
The acute percutaneous toxicity of BCI-MX was investigated in a group of 5 male and 5 female CD rats. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bw, and was covered by an occlusive dressing for 24 hours. Mortality and systemic or local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were killed on the following day and subjected to necropsy.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals.
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: none
Body weight:
All animals achieved expected bodyweight gains.
Gross pathology:
Effects on organs: none
Other findings:
Signs of toxicity (local): none
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 dermal > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity study (limit test) was performed on male and female Sprague-Dawley rats according to OECD TG 402. No mortalities, clinical signs or local effects were observed during the 14 -day observation period. The resulting dermal LD50 was > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and has Klimisch score 1.

Additional information

The acute oral toxicity of the test item was evaluated in a GLP-compliant study (limit test) on male and female Sprague-Dawley rats according to OECD TG 401. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical sign piloerection was observed on the day of treatment only.

An acute dermal toxicity study (limit test) was performed on male and female Sprague-Dawley rats according to OECD TG 402. No mortalities, clinical signs or local effects were observed during the 14 -day observation period. The resulting dermal LD50 was > 2000 mg/kg bw.


Justification for classification or non-classification

The acute oral and dermal toxicity was proven to be low with LD50 values of > 2000 mg/kg.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.