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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-10-05 to 1983-11-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented scientifically sound acute dermal study similar to OECD guidelines and following GLP. The skin of one male and one female from each dose group was abraded prior to treatment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Skin of 1 male and 1 female in each group was abraded
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-22-20
- Physical state: Light yellow liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
- Other: Base factor: Specific gravity = 0.952 g/ml; 1 quart supplied on September 26, 1983; the purity of the test article was the responsibility of the sponsor

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA and Perfection Breeders, Douglassville, PA
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit RationR, ad libitum
- Water: Fresh tap water, suitable for human consumption, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: No less than 20% of the dorsal body surface area
- Type of wrap if used: A layer of gauze covering the dosed area; animals were then wrapped with rubber dam and an ace bandage to retard evaporation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
Duration of exposure:
24 h
Doses:
4000, 5000, 6300, 8000 mg/kg
No. of animals per sex per dose:
2 per sex per dose (16 in total), the skin of one male and one female from each dose group was abraded prior to test substance application.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 2 and 4 hours after the 24 hour exposure period, and twice daily thereafter for 14 days.
- Necropsy of survivors performed: yes
Statistics:
By the method of Litchfield and Wilcoxon (1949) JPET 96:99-114

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 700 mg/kg bw
95% CL:
4 400 - 7 300
Mortality:
Male: 4000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 2; Number of deaths: 1
Male: 6300 mg/kg bw; Number of animals: 2; Number of deaths: 2
Male: 8000 mg/kg bw; Number of animals: 2; Number of deaths: 1
Female: 4000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 2; Number of deaths: 1
Female: 6300 mg/kg bw; Number of animals: 2; Number of deaths: 1
Female: 8000 mg/kg bw; Number of animals: 2; Number of deaths: 2
Clinical signs:
other: None of the rabbits died at 4 g/kg, two of four rabbits died at 5 g/kg and three of four died at 6.3 and 8 g/kg. Signs observed included necrosis, severe to moderate erythema and edema of the application sites and surrounding areas, decreased activity, ab
Gross pathology:
Necropsy of animals dying on study revealed pale livers with necrotic areas on all lobes. Pale kidneys and hemorrhages of the muscle layers underlying the application sites were also observed.
Terminal necropsy revealed hemorrhages of the muscle layers under the application sites.

Any other information on results incl. tables

No notation regarding effects of abrasion were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The calculated LD50 for the test material was determined to be 5700 mg/kg with 95% confidence limits of 4400 to 7300 mg/kg. The substance is considered not classified as acute dermal toxicant.