Hexamethylene diisocyanate, oligomerisation product, blocked with 2-butanone oxime

Acute Toxicity: dermal

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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:

other: No clinical signs observed in male animals. Partial reddening, encrustration and formation of scale of the treatment area were observed in females.

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.