Benzenesulfonic acid, C14-24-alkyl derivatives, magnesium salts, overbased

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, petroleum, calcium salts

EC Number:

263-093-9

EC Name:

Sulfonic acids, petroleum, calcium salts

Cas Number:

61789-86-4

Constituent 2

Reference substance name:

petroleum derived calcium salt

IUPAC Name:

petroleum derived calcium salt

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.