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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:
Study completion date - 06 October 1976.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
EC Number:
264-129-6
EC Name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
Cas Number:
63405-85-6
Molecular formula:
C20H18N4O5S.Na
IUPAC Name:
sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Housing: The rabbits were housed individually in suspended, wire-bottomed cages and maintained on a standard laboratory.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: All rabbits had been maintained under observation in the laboratory for at least seven days prior to testing.

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:

TEST SITE
- Area of exposure: Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers.
- % coverage: The shaved area on each animal constituted about 30 percent of the total body surface area.
- Type of wrap if used: The test site was covered by wrapping the trunk of the animal with impervious plastic sheeting which was securely taped in place

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours

Duration of exposure:
24 hours
Doses:
3000 mg/kg body weight
No. of animals per sex per dose:
4 animals/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Statistics:
No statistical analysis was used.

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
The body weights were recorded on day 0, 7 & 14 of the test.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
None

Any other information on results incl. tables

Mortality & Body Weight Data:

Dose level (mg/kg) Animal Number & Sex Individual Body Weights (kg) Number Dead Percent Dead
0 7 14 Number Tested
3,000 1 - M* 2.7 2.88 3.02 0/4 0
2 - M 2.7 3.08 3.08
3 - F* 2.8 3.1 3.1
4 - F 2.68 2.86 2.86

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of FAT 20004 after single dermal administration to rabbits of both sexes, observed over a period of 14 days is: LD50 (rabbit): >3000 mg/kg body weight.
Executive summary:

A key study was performed to determine the acute dermal toxicity of FAT 20004 on New Zealand rabbits over a period of 14 days. The test substance was applied at a dose of 3000 mg/kg body weight. The test site was covered by wrapping the trunk of the animal with impervious plastic sheeting which was securely taped in place. The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and all residual test material were removed. The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications. Initial, 7 and 14-day body weights were recorded. A necropsy examination was conducted on all animals. No pharmacotoxic symptoms were observed in the rabbits following dermal exposure to FAT 20004. The material stained the skin of the albino rabbit. Due to this, skin reactions (erythema or burns) at 24 hours could not be evaluated. No skin changes were noted at 7 and 14 days. Necropsy examination did not reveal any gross pathologic alterations. The median lethal dose of FAT 20004 after single dermal administration to rabbits of both sexes, observed over a period of 14 days is: LD50 (rabbit): >3000 mg/kg body weight.