Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles river Japan- Age at study initiation: 6 weeks old- Weight at study initiation: 243 to 272g for males & 156 to 173g for females- Housing: rectangular suspension cage with a stainless steel wire mesh floor- Diet (e.g. ad libitum): laboratory animal chows (CRF-1, sterilised by CO irradiation, Oriental Yeast Co. Ltd.) ad libitum- Water (e.g. ad libitum): free access to tap water ad libitum- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 24+-2°C- Humidity (%): 55+-10%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): fluorescent lighting system - 12 hours light/dark cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
The suspension was spread over the shreaded area (30 cm2) using a plastic syringe (2.5ml) and an attached gastric metal probe with a plastic tip (1.2 mm in diameter, 80 mm in length) at the dosing volume of 10 ml/lg body weight. The treated area was then covered with surgical tape to prevent the animals from licking the test material from the treated area.
Duration of exposure:
24 hours
Doses:
The test material was suspended in 0.5% methylcellulose aqueous solution (MC) at the concentration of 200 mg/ml.
No. of animals per sex per dose:
5 animals per group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: 1, 2 and 4 hours after administration on the first day and once daily for 2 weeks thereafter- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
The mortality and LD50 values were calculated.

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in the animals
Clinical signs:
No abnormal signs were observed.
Body weight:
There was no difference in the mean body weight and the mean body weight gain between treated groups and the control group at every determination.
Gross pathology:
Retention of white substances in the urinary bladder (male) and distended uterine horns with fluid retention were found in several animals including controls. These changes have been occasionally found in untreated rats in this laboratory.No skin irritative reaction was observed at the application site. Therefore, no remarkable change related to the administration of the test material was found.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, FAT 40554 did not show acute dermal toxicity.
Executive summary:

An acute dermal toxicity test of D-523 was examined in rats according to EU Method B.3 (Acute Toxicity (Dermal).

5 animals per group were administered the suspension with a dose of 200 mg/ml in 0.5% methylcellulose aqueous solution (MC).

Neither abnormal signs nor dead animals were found in any group among animals of either sex, and the acute dermal LD50 value for both males and females was estimated to be greater than 2000 mg/kg body weight.

The body weight was not affected by the administration of the test material. In gross pathology, there was neither a remarkable change related to the test material nor a skin irritative reactions at the application site in any animal.

Therefore, the FAT 40554 did not show any acute dermal toxicity in animals.