Benzenesulfonic acid, di-C10-14-alkyl derivs.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: Read-across based on the closest structural analogues for which high quality data were available, obtained through membership in the ATC TF-25 Consortium.

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

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

Test material information

Constituent 1

Reference substance name:

115733-09-0

Cas Number:

115733-09-0

IUPAC Name:

115733-09-0

Constituent 2

Reference substance name:

C14-24 alkaryl calcium salt derivative

IUPAC Name:

C14-24 alkaryl calcium salt derivative

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:

other: 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 observati

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.