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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
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:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
animal skin was abraded prior to dosing
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
the test substance was a similar material to the registered substance (aryl alkyl sulphonate)

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 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
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:
Animals showed distress at bandage removal 24 hours following dosing. Skin at the administration site was red, swollen and stained with test material. Irritation subsided by day 9, however, the skin remained dry, flaky and stained throughout the observation period.

On termination, 9 rabbits exhibited alopecia, matted fur and flaky skin at or around the test site.
Body weight:
No significant change in bodyweight occurred in treated animals.
Gross pathology:
One animal had a friable, white, mottled left liver lobe. One animal had a small right testis.

Any other information on results incl. tables

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

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

5000

 0/5

 0/5

0/10 

 

 5/5

 5/5

10/10

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality has occurred at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000mg/kg
Executive summary:

In an acute dermal toxicity study, groups of New Zealand white rabbits (5/sex) were dermally exposed for 24 hours to C14-24 alkaryl calcium salt derivative at doses of  5000 mg/kg bw.  Animals then were observed for 14 days.

No mortality occurred in this limit test, therefore an LD50 has not been determined.

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