Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restriction, GLP guideline study
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:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Desmodur BL 3175 SN
IUPAC Name:
Desmodur BL 3175 SN
Details on test material:
- Name of test material (as cited in study report): HDI Trimer MEKO-blocked, approx. 75% in solvent naphta 100; DESMODUR BL 3175 SN

- Physical state: colorless liquid
- Analytical purity:

- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: LDT7090027
- Expiration date of the lot/batch: 2010-06-16

- Stability under test conditions:
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, GmbH
- Age at study initiation: 9-13 weeks
- Weight at study initiation: male: 272-286g; female: 233-255g
- Fasting period before study: no fasting period
- Housing: caged individuallyin polycarbonate cageson low dust wood granulate bedding
- Diet (e.g. ad libitum): standard diet "Provimi kliba 3883 PM S15 Maus/Ratte haltung, Kaiseraugst Switzerland
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 5°C
- Air changes (per hr): approx. 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours rythm


IN-LIFE DATES: From: To: No data

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approx 10% of the body surface area
- Type of wrap if used: a gauze-layer (6.0 cm * 5.0 cm) of a Cutiplast* steril coeated with air-tight Leukoflex*


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the are was rinsed with tepid water using soap and gently aptting the area dry
- Time after start of exposure: after appro. 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): males: 18.1-19.1 mg/cm2; females: 15.5-17.0 mg/cm2
- Concentration (if solution):



VEHICLE: no vehicle
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
2667 mg/kg bw of DESMODUR BL 3175 SN.
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 and weighing:
Clinical observations and mortality: several times on the day of application and at least once a day during observation period
Weight:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 667 mg/kg bw
Mortality:
No mortality
Clinical signs:
No clinical signs observed in male animals. Partial reddening, encrustration and formation of scale of the treatment area were observed in females.
Body weight:
No toxicologically significant effects on body weight or body weight development in males and females. The slight decrease in body weight gain in
females the first week is assumed to be caused by the stress of the application procedure.
Gross pathology:
No particular findings.
Other findings:
No data

Any other information on results incl. tables

Dose (mg/kg bw)

Toxicological results*

Occurrence of signs

Time of death

Mortality (%)

Male     2000**

0 / 0 / 5

-

-

0

Female 2000**

0 / 5 / 5

2d – 13d

-

0

*number of animals which died spontaneously and/or were sacrificed in moribund state / number of animals with signs of toxicity / total number of animals used per groups used per group

** expressed as HDI Trimer MEKO blocked

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 SN (75% HDI Trimer MEKO blocked in 25% solvent naphta 100) is not classified for acute
dermal toxicity according to the criteria of the CLP regulation (EC) N°(1272/2008) and the Annex VI to the Directive 67/548/EEC.
Executive summary:

In an acute dermal toxicity study, performed according to OECD 402, in compliance with GLP, 5 rats Wistar by sex were applied with DEMSODUR BL 3175 SN (75% HDI Trimer MEKO blocked in 25% solvent naphta 100) at a concentration of 2667 mg/kg bw.

No mortality, no clinical signs in male, no effect on body weight have been observed. Artial reddening, encrustration and formation of scale of the treatment area were observed in females.

LD50>2667 mg/kg bw .

DESMODUR BL 3175 SN is not classified for acute dermal toxicity according to the criteria of hte CLP regulation (EC) N°(1272/2008) and the Annex VI to the Directive 67/548/EEC.