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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines and GLP, but not fully reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hour
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: On day of dosing and day 7 and 14 following dosing.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs observed each day
Statistics:
No mortality occurred. Use of statistics not indicated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: 95% CL not indicated.
Mortality:
Mortality did not occur in treated animals.
Clinical signs:
Reduced food intake and nasal discharge were observed in treated and control animals. Slight to moderate erythema and oedema were observed in 3 animals on day 7. Dry and flaky skin was observed in all treated animals on days 6 and 14.


Body weight:
No significant change in bodyweights occurred in treated animals.
Gross pathology:
Dry, flaky skin occurred at the dose site of all treated animals. Mild hyperkeratosis was found on microscopic examination.

Any other information on results incl. tables

Dose
(mg/kg bw)

Conc.
in vehicle (%)*

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

Control

Control

 0/5

0/5 

0/10

 -

 0/5

0/5

 0/10

5000

-

 0/5

0/5

0/10 

 -

 5/5

5/5

10/10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality did not occur at doses of 5000 mg/kg. Therefore, the LD50 > 5000 mg/kg.
Executive summary:

In an acute dermal toxicity study, groups of New Zealand white rabbits (5/sex) were given a single dermal dose of petroleum derived calcium salt at 5000 mg/kg bw and observed for 14 days.

No mortality occurred in this limit test. Therefore, the LD50 > 5000 mg/kg.

This acute study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rabbit.