Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-conducted GLP study, according to guideline
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Richtlinie 84/449/EWG, test protocol corresponds to OECD 401, LImit Test
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Desmodur BL 3175
IUPAC Name:
Desmodur BL 3175
Details on test material:
- Name of test material (as cited in study report): Desmodur BL 3175
- Molecular weight (if other than submission substance): 830 g/mol
- Physical state: colourless, viscous liquid
- Stability under test conditions: analytically prooved (see final report of analytics, of 1991-07-25)
- Batch number:
- Purity: approximately 75% in Solventnaphta 100

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males appr. 8 weeks, females appr. 10 weeks
- Weight at study initiation: males mean 185 g, females mean 175 g
- Fasting period before study: 16 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
limit test, no statistics required

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: dose was tolerated without mortalities, body weight changes or clinical signs of toxicity
Mortality:
None
Clinical signs:
None
Body weight:
Not influenced by treatment
Gross pathology:
No unusual lesions were noted in any of the animals
Other findings:
No other findings

Any other information on results incl. tables

Number of animals dead [and with evident toxicity] [and time range within which mortality occurred

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

2000

0

0

0

-

0

0

0/10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, DESMODUR BL 3175 is not classified for acute oral toxicity according to the Annex VI to the Directive 67/548/EEC and the CLP
Regulation (EC) N°( 1272-2008).
Executive summary:

In an acute oral toxicity study, conducted according to OECD 401 guideline, in compliance with GLP, 10 Wistar rats (5 by sex) were given a single oral dose of Desmodur BL 3175 in propylene glycol (10 ml/kg bw) at dose of 2000 mg/kg bw.

The LD50 in rats was determined > 2000 mg/kg bw for the preparation. This dose was well-tolerated without mortalities, body weight changes or clinical signs of toxicity.

Therefore, DESMODUR BL 3175 is not classified for acute oral toxicity according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N°( 1272-2008).