Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1995-02-08 to 1995-02-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 402 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP compliance programme (inspection date: 1992-10-27)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: clear colorless liquid
Specific details on test material used for the study:
Storage conditions: 4 °C in the dark

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
Crl:CD(SD)BR strain (VAF plus)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: 9-10 weeks
- Weight at study initiation: approximately 200 g
- Fasting period before study: no
- Housing: individually housed in grid bottomed cages suspended over cardboard lined excreta trays.
- Diet (e.g. ad libitum): pelleted rodent diet ad libitum (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%): 31-62 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: on the back
- % coverage: 10 %
- Type of wrap if used: gauze was covered with a strip of aluminium foil. The trunk of each animal was encircled with a length of 5 cm wide non-irritant surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): determined from the individual bodyweight of each animal
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: approximately 30 minutes, 1, 2 and 4 hours afters dosing and thereafter for 14 consecutive days.
Weighing: on the day of dosing, on days 8 and 15.
- Necropsy of survivors performed: yes, including opening of the thoracic and visceral cavities, and opening and examination of the stomach and representative sections of the gastro-intestinal tract and examinations of the major organs. Abnormal tissues and organs were preserved in neutral buffered formaldehyde but were not processed further.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
All animals maintained a healthy appearance throughout the 15 day observation period. A scab was noted on the head of one male on Day 15 but this was not considered to be treatment related.
Body weight:
There was no adverse effect on bodyweight gain in animals of either sex.
Gross pathology:
At necropsy, moderate pelvic dilation of the right kidney and swelling of the left submandibular lymph node were noted on one animal. No abnormalities were detected in the remaining animals.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Dermal LD50Combined > 2000 mg/kg bw
Executive summary:

In a limit acute dermal toxicity study performed according to the OECD guideline No. 402 and in compliance with GLP, groups of young adult Crl:CD(SD) rats (5/sex) were occlusively exposed to undiluted ST 06 C 93 at a dose level of 2000 mg/kg bw. After a contact period of 24 h, the dressings were removed and the treated skin cleansed with water. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

No deaths occurred during the study. All animals maintained a healthy appearance throughout the 15 day observation period. A scab was noted on the head of one male on Day 15 but this was not considered to be treatment related. There was no adverse effect on bodyweight gain in animals of either sex. At necropsy, moderate pelvic dilation of the right kidney and swelling of the left submandibular lymph node were noted on one animal. No abnormalities were detected in the remaining animals. 

 

Dermal LD50Combined > 2000 mg/kg bw

 

Under the test conditions, ST 06 C 93 is not classified according to the the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.