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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-09-11 to 1980-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1981-05-12
Deviations:
yes
Remarks:
substance was tested on abraded skin; removal of substance was not described; area covered by test substance was not exactly stated; body weight was not determined weekly; information on strain of rabbit was missing
Principles of method if other than guideline:
It has to be mentioned that no OECD guideline was available at the time of conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Naphthenic acids, zinc salts
EC Number:
234-409-2
EC Name:
Naphthenic acids, zinc salts
Cas Number:
12001-85-3
IUPAC Name:
zinc bis[3-(3-ethylcyclopentyl)propanoate]
Test material form:
other: solid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS - albino rabbits
- Weight at study initiation: between 2.0 and 3.0 kg; average initial weight: 2.33 kg (males) and 2.27 kg (females)
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure and type of wrap used: all animals had their backs clipped free of hair 24 hours prior to testing. All of the animals had their backs abraded prior to dosing.
All rabbits were weighed and the correct amount of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed after the exposure period and any excess material was removed and the approximate amount remaining was noted.
- Time after start of exposure: 24 hours after application of the test material


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for a 14 day period for signs of toxicity and for mortalities.
- Necropsy of survivors performed: yes
Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period.
Statistics:
not stated

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: Except for very substantial skin irritation lasting throughout the course of the observation period, no other untoward symptoms were observed.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
LD50 (male and female rabbits; abraded skin) > 2000 mg/kg
According to the EC-Regulation 1272/2008 and its subsequent amendments, the test item is not classified as acute toxic via the dermal route.