TDI Biuret

Acute Toxicity: oral

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates

IUPAC Name:

Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates

Details on test material:

- Name of test material (as cited in study report): Desmodur VP.PU 60WF14
- Physical state: viscous liquid
- Purity: 100 % (as indicated by the sponsor)
- Lot/batch No.: P1DE000345
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan GmbH, Horst, Netherlands
- Strain: HsdCpb:Wu
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 171-195 g
- Fasting period before study: 16-24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: corn oil with the aid of 10 % acetone (dried with molecular sieve)

Details on oral exposure:

- Application volume: 20 ml/kg bw

- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none (limit test)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

other: LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Mortality:

All 6 animals survived the treatment.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross pathological findings were observed.

Other findings:

none

Any other information on results incl. tables

NOEL: 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category V

Remarks:

Migrated information

Executive summary:

A single oral dose of 2000 mg/kg body weight was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 cut-off of Desmodur VP.PU 60WF14 is > 5000 mg/kg bw for rats (Category 5 / unclassified of the Globally Harmonized Classification System).