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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 January - 9 February 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Product name: Tolgard V6
Appearance: colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, UK
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 200 - 291g
- Housing: maximum 5 animals of same sex in polypropylene cages
- Diet: ad libitum (Expanded Rat and Mouse Maintenance Diet)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Mean relative humidity (%): 48
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: at least 10% of body surface
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24h
Duration of exposure:
24 hours
Doses:
- Range finding study: 400, 1000, 1500 and 2000 mg/kg
- Main study: 2000 mg/kg
No. of animals per sex per dose:
- Range finding study: 2 males and 2 females per dose level
- Main study: 5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on day of dosing and 14 days following dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:
No deaths, no clinical signs and no gross post mortem observations noted
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during study period
Clinical signs:
No clinical signs noted
Body weight:
Body weight gains were in the normal range.
Gross pathology:
No abnormalities at post mortem examination noticed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median dermal lethal dose (LD50) of the test substance in rats is greater than 2000 mg/kg
Executive summary:

In an acute dermal toxicity study conducted according to OECD Guideline No.402, 5 male and 5 female Sprage-Dawley rats were treated with undiluted2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) at a dose level of 2000 mg/kg for 24 h under occlusive conditions. After removal of the test substance by washing the animals were observed for 14 days. No deaths and clinical signs have been observed in any of the tested animals. At post mortem examination no abnormalities were detected and body weight gains during the course of the study were normal.

Dermal LD50 males > 2000 mg/kg bw

Dermal LD50 females > 2000 mg/kg bw