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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: R7623 Technical, solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 1% aqueous methyl cellulose
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
Duration of exposure:
24 hours
Doses:
dose volume was 10 mL/kg bodyweight and the dose level was 2000 mg/kg bodyweight
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: <14 days>
- Frequency of observations:
- Frequency of weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Other findings:
- Organ weights:
- Histopathology:
- Potential target organs:
- Other observations:

Any other information on results incl. tables

Clinical observations:

No mortality occurred and no signs of systemic toxicity were observed during the 14 day observation period. The treated skin surface of one animal (day 4) and another animal (day 7) showed small wounds and small scabs. All animals showed bodyweight gain during the study period.

Macroscopic findings:

Macroscopic examination at necropsy of all animals at the end of the study revealed no test substance related gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC, Annex VI if the EEC Directive 67/548/EEC
Conclusions:
LD50 = 2000 mg/kg bodyweight
Based on the results of this study it is concluded that the test substance has no toxic effect when administered as a single dermal dose to the rat at a dose level of 2000 mg/kg bodyweight. According to the general classification and labelling requirements for dangerous substance (EEC Directive 83/467/EEC, Annex VI if the EEC Directive 67/548/EEC) the test substance should be classified as nontoxic.
Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, received a single dermal dose of R7623 Technical at 2000 mg/kg bodyweight for 24 hours. No mortality occurred during the 14 day observation period. The treated skin surface of the animals showed no major irritant effect. Macroscopic examination at necropsy of all animals at the end of the study revealed no treatment related gross abnormalities. Since no mortality occurred, the dermal LD50value for males and females is given as exceeding 2000 mg/kg bodyweight.