Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with GLP and guidelines and sufficient data is available for the interpretation of study results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): T -4388
- Physical state: Colorless liquid
- Lot/batch No.: ( 6 )
- Storage condition of test material: Stored in the dark under ambient conditions.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River ( UK )
- Age at study initiation: 8-10 weeks
- Weight at study initiation:211-297g
- Fasting period before study: not specified
- Housing: The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum number of 5 animals per cage
- Diet ( ad libitum): Expanded rat and mouse maintenance diet supplied by special diet services
- Water ( ad libitum): Tap water ad libitum
- Acclimation period: 9 days


ENVIRONMENTAL CONDITIONS
- Temperature °C: Mean environmental maximum and minimum temperatures were 21°C and 19°C
- Humidity (%): Mean relative humidity 40 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark /12 hrs light


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:clipped intact skin of the back
- % coverage: 10 % of body surface
- Type of wrap if used: Strip of non-irritating material


REMOVAL OF TEST SUBSTANCE
-After the contact period (24 hours) dressing was removed and the skin wiped with a water dampened tissue to remove excess test material


Duration of exposure:
24 hrs
Doses:
500, 1000, 1500, 2000 mg/kg for range finding study
2000 mg/kg for main study
No. of animals per sex per dose:
2 males and 2 females/dose level for range finding study
5 males and 5 females for main study
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed frequently on the day of dosing and for 14 days following dosing. Rats were weighed immediately prior to dosing, 7 days after dosing and at the end of 14 day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and Necropsy findings

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived.
2000 mg/kg (Males ) - 0/5
2000 mg/kg (Females ) - 0/5
Clinical signs:
There were no deaths and no clinical signs were noted.
2000 mg/kg (Males ) - No clinical signs observed
2000 mg/kg (Females )
Body weight:
All animals showed body weight gain over the 14 day observation period.
Gross pathology:
No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the median lethal dose (LD50) of T-4388 in rats is greater than 2000 mg/kg.
Executive summary:

The acute dermal toxicity potential of test material, T-4388 (Colorless liquid) was investigated in 5 males and 5 females Sprague-Dawley rats. Doses selected for range finding study were 500, 1000, 1500, 2000 mg/kg and 2000 mg/kg for the main study

Rats were received from Charles River (UK) and all received rats were kept for 9 days acclimatization period. Animal rooms were maintained at a temperature 19-21°C and relative humidity of 40 % with 12 hrs dark /12 hrs light photoperiod. The rats were fed expanded rat and mouse maintenance diet supplied by special diet services with ad libitum tap water. The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum number of 5 animals.

Rats were prepared by clipping the backs free of hair, approximately 24 hours before application of test material. The test material, as supplied was applied evenly onto gauze dressing which was applied to shaved back of each rat. Up to at least 10 % of the body surface was in contact with the test material. The trunk of the rat then encircled with as strip of non-irritating tape. After the contact period (24 hours) dressing was removed and the skin wiped with a water dampened tissue to remove excess test material. Rats were observed frequently on the day of dosing and for 14 days following dosing and weighed immediately prior to dosing, 7 days after dosing and at the end of 14 day observation period. At the end of observation period all the animals were sacrificed by carbon dioxide asphyxiation.                

All animals showed body weight gain over the 14 day observation period. There were no deaths and no clinical signs were noted at 2000 mg/kg dose level. No abnormalities were detected at necropsy. Based on the results of this study the median lethal dose (LD50) of T-4388 in rats is greater than 2000 mg/kg.According to EU this test material is not classified.