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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

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:
yes

Test material

Constituent 1
Reference substance name:
Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
Cas Number:
85187-33-3
Molecular formula:
C26H19BrN4Na2O9S3
IUPAC Name:
Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder
Details on test material:
Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature
Specific details on test material used for the study:
'Lanasol Red 6G, Product #01- 146394- 100-0, Batch No. 78316/11 (DCT No. 8-0053), brownish-red powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, Pennsylvania
- Weight at study initiation: 2.3 and 3.0 kgs
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
warm
Details on dermal exposure:
24 hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper exposing approximately 30 % of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. The animals were then returned to their individual cages and observed for toxic signs and survival.
Duration of exposure:
24 hours
Doses:
3 gm/kg of body weight
No. of animals per sex per dose:
6 animals per dose
Control animals:
not specified

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
There were no adverse clinical signs observed in any of the six animals throughout the study.
There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study.
Body weight:
All animals displayed an acceptably consistent weight pattern over the 14 days
Gross pathology:
Necropsies revealed all organs to be within normal limits

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.
Executive summary:

A acute toxicity study via dermal route was performed on New Zealand albino. The test material was applied, in the quantity of 3000 mg/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. Six animals were used in the study. There were no mortality observed. There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study. All gross necropsies were within limits. Based on the findings, an acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.

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