Registration Dossier

Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
EC Number:
238-200-7
EC Name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
Cas Number:
14285-59-7
Molecular formula:
C32H16CoN8O12S4
IUPAC Name:
tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
The rabbits were acclimated to the laboratory for at least four days before dosing. The dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers.

Administration / exposure

Type of coverage:
open
Vehicle:
physiological saline
Details on dermal exposure:
The rabbits were acclimated to the laboratory for at least four days before dosing. The dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers. The abdominal skin area of half of the rabbits in each group was abraded by making a series of longitudinal minor epidermal incisions placed two to three centimeters apart, using a hypodermic needle as a cutting tool. The abrasions were sufficiently deep to penetrate the epidermis, but not to induce bleeding. The undiluted sample was moistened with sufficient physioloical saline to form a paste and was applied at a dosage level of 2.0 g/kg of body weight.
Duration of exposure:
24h
Doses:
2 g/ kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
At the end of the 24-hour exposure period the binder was removed and any unabsorbed sample remaining on the skin was removed by gentle sponging with a moistened towel. Each rabbit was examined thoroughly for gross signs of systemic toxicity and dermal irritation. The rabbits were housed in individual stainless steel cages suspended above the droppings. Food, consisting of Purina Laboratory Chow, and water were available at all times. The animals were kept on a 12-hour light/12-hour dark cycle.
All rabbits were maintained for 14 days following completion of the expo¬ sure period. Examinations for gross signs of systemic toxicity and dermal irritation were carried out at frequent intervals during this period. At the end of the 14-day observation period the rabbits were weighed, sacrificed by T-61 overdose, and a gross necropsy was performed on each animal.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occured
Clinical signs:
other: Irritative and systemic effects noted during the course of the study included erythema, edema, desquamation, coriaceousness, and emaciation
Gross pathology:
Gross necropsies performed at the termination of the study revealed pitted kidneys in rabbit #5 and rabbit #9. No other gross pathological alterations or lesions were noted in the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Acute Dermal LD50 (lethal dose for 50% of the animals) of the test material was found to be greater than 2.0 g/kg of body weight for New Zealand White rabbits.

Under tests conditions, test material do not require classification for acute dermal toxicity.

Categories Display