Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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:
1981

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Crude cyanuric acid
- Physical state: off-white solid balls
- Lot/batch No.: Lot 3-30-81

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois, USA
- Age at study initiation: Young adults
- Weight at study initiation: 2.51 – 2.79 kg
- Diet (e.g. ad libitum): provided ad libitum
- Water (e.g. ad libitum): provided ad libitum




Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal surface
- % coverage: 10%
- Type of wrap if used: Latex rubber


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test material wiped from animal
- Time after start of exposure: ~ 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg

Duration of exposure:
~ 24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made 3 times during the first 8 hours of the study and twice daily thereafter. Body weights recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes (day 15)
Statistics:
None applied

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities occurred.
Clinical signs:
No clinical abnormalities were observed.
Body weight:
No effects on body weights were noted.
Gross pathology:
Pale kidneys in one male, pale, mottled kidneys in one female, tapeworm cysts in one female. None of the effects were attributed to toxicity of the test material.

Any other information on results incl. tables

Males: No clinical abnormalities were observed. No necropsy findings were attributed to toxicity of the test material. One animal had pale kidneys.

Females: No clinical abnormalities were observed. No necropsy findings were attributed to toxicity of the test material. One animal had pale mottled kidneys and another had tapeworm cysts in the mesentery.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
LD50 (dermal, rabbit) > 5000 mg/kg