BMS 233110-01

Endpoint summary

Description of key information

BMS 233110-01 was tested for acute oral toxicity on Sprague-Dawley male and female rats, according to EU Test Method B.1 bis (fixed dose procedure). No deaths were observed on male and female rats at the 50 and 200 mg/kg bw dose, while 1 of 2 female rats died at the dose level of 500 mg/kg bw. Based on this, the oral LD50 for the substance was estimated to be >200 and <2000 mg/kg bw. This is sufficient to classify the substance as acute toxic, category 4, according to CLP.

 

A study was carried out on male and female Sprague-Dawley rats to determine the acute dermal (systemic) toxicity potential for substance BMS 233110 -01, according to EU Test Method B3, Part 3 of Directive 92/69/EEC and OECD Test Guideline No 402. None of the 5 male and 5 female rats died when exposed to doses of 2000 mg/kg bw. Therefore, the LD50 value for dermal exposure is greater than 2000 mg/kg bw. As a result, the substance is not classified as acute dermal toxic.

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:

24th August - 28th September 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Principles of method if other than guideline:

An additional group of 1 + 1 was exposed at 200 mg/kg.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Identity of test material same as for substance defined in section 1

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Vehicle:

arachis oil

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 500 mg/kg bw; Number of animals: 1; Number of deaths: 0
Male: 200 mg/kg bw; Number of animals: 1; Number of deaths: 0
Male: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 1; Number of deaths: 1
Female: 200 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: In the preliminary study, the female rat died 3 days after dosing. The male rat had significant clinical signs which resolved after 9 days. Clinical signs became apparent 1 hour after dosing and included hunched

Gross pathology:

Effects on organs:
There were no abnormalities recorded at necropsy in the main group. Examinations were not performed in the other groups.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The discriminatory dose was identified as 50 mg / kg bodyweight. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley Strain rat was estimated to be greater than 200mg/kg but less than 2000mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

1

Acute toxicity: via inhalation route

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:

6th - 22nd July 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Identity of test material same as for substance defined in section 1

Species:

other: Rat, Crl:WI(Glx

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

other: Substance was applied to skin moistened with water.

Duration of exposure:

24 hrs

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:

other: Signs of toxicity related to dose levels: No signs of toxicity were observed.

Gross pathology:

Effects on organs:
There were no remarkable findings during necropsy considered to be treatment related.

Other findings:

Signs of toxicity (local):
No dermal effects were noted and other than staining of the snout and anogenital soiling in a small number of animals.

These observations are frequent under the conditions of this type of study and are not considered to be toxicity related.

Interpretation of results:

GHS criteria not met

Conclusions:

Acute dermal toxicity: LD50 > 2000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

1