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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:
other: Pre-guideline and pre-GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Noakes, D.N. and Sanderson, D.M. A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med., 26, 59-64, 1969
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of trientine and trientine, mono- and di-propoxylated
EC Number:
942-835-1
Molecular formula:
(C6 H18 N4 . C3 H6 O)x
IUPAC Name:
Reaction mass of trientine and trientine, mono- and di-propoxylated
Test material form:
other: Weighed concentrate
Details on test material:
No details reported

Test animals

Species:
rat
Strain:
other: Tif:RAI/F
Sex:
male/female
Details on test animals or test system and environmental conditions:
During treatment and for the 7 day observation period the rats were housed singly in Macrolon cages (Type 3) in a room kept at a constant temperature of 22± 1°C and a relative humidity of approximately 50%. They were given water and food (NAFAG, Gossau. SG, rat food) ad libitum. The animals were bred in-house, they were 7 to 8 weeks old and weighed 180 to 200 g.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 6 hours before treatment the rats'backs were shaved with an electric razor. The suspension was evenly dispersed on the skin with a
Record syringe and covered with aluminium foil, which was held around the trunk with ISO-ELAST plaster. After 24 hours the plaster and the
aluminium foil were peeled off carefully and the skin was cleaned with warm water to remove all traces of the suspension. The rats were the observedfor a 7-day period and symptoms recorded.

Duration of exposure:
24 hours
Doses:
2150 mg/kg (for technical reasons higher doses were not possibel)
No. of animals per sex per dose:
The compound was tested on 6 Tif.: RAI/f rats (3 male and 3 female), bred under SPF conditions They were 7 to 8 weeks old and weighed 180
200 g.
Control animals:
not specified
Details on study design:
Shaved backs of Rats were treated with an even dispersion of a weighed concentrate (2150 mg/kg) of the test material and covered with aluminium foil for a period of 24 hours. After 24-hours the aluminium foil was removed and the treatment site was cleaned with warm water to remove all traces of the suspension. The rats were obseved for 7-days and symptoms recorded.
Statistics:
Not applicable

Results and discussion

Preliminary study:
No details
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 150 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed
Clinical signs:
other: No symptoms and no local skin irritation were observed. The rats were killed and autopsied after an observation period of 7 days.
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
Not applicable

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute dermal LD50 of the test material in rats of both sexes observed over a period of 7-days was >2150 mg/kg
Executive summary:

The acute dermal toxicity (LD50) in rats of both sexes was tested and observed over a period of 7-days. The shaved backs of Rats were treated with an even dispersion of a weighed concentrate (2150 mg/kg) of the test material and covered with aluminium foil for a period of 24 hours. After 24-hours the aluminium foil was removed and the treatment site was cleaned with warm water to remove all traces of the suspension. The rats were obseved for 7-days and symptoms recorded.

During the test no mortality, no symptoms and no local skin irritation were observed during the 7 -day observation period. No substance related gross organ changes were seen during autopsy.

The acute dermal LD50 of the test material in rats of both sexes observed over a period of 7-days was >2150 mg/kg