Benzenesulfonic acid, mono-C20-24 (even)-sec-alkyl derivs., para-, sodium salts

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:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD Guidelines and to GLP, but not fully reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

Analogue of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

IUPAC Name:

Analogue of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

Details on test material:

The test material was an analogue of CAS 70024-69-0 described as C20-C24 alkaryl calcium salt derivative.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Approximately 24 hour prior to topical application of the test material, the hair of each control and treated animal was closely clipped.
A single dose of 2000 mg/kg of the undiluted test material was administered dermally to five male and female animals.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dose level: 2 g/kg
Dose volume not specified

Duration of exposure:

24 hours

Doses:

2000 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:

None, there was no mortality.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 2000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: No clinical signs of toxicity were observed in treated animals.

Gross pathology:

Skin irritation was observed for all treated animals. Multiple pinpoint scabs were observed in 3 treated males and 1 treated female.

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
Control		0/5	0/5	0/10		0/5	0/5	0/10
2000		0/5	0/5	0/10		5/5	5/5	10/10

No signs of systemic toxicity were observed. All treated animals exhibited skin irritation. Significant differences in mean body weight were observed between treated and control males on days 2, 7 and 14. At necropsy, multiple pinpoint scabs were observed in three treated males and one treated female.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

No mortality occurred at a maximum tested level of 2000 mg/kg bw and the study has been completed as a limit test. The LD50 is considered to be more than 2000 mg/kg.

Executive summary:

In an acute dermal toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of the calcium sulfonate read across substance (Analogue of CAS 70024-69-0), at 2000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test; therefore an exact LD50 has not been determined. The test article, when administered dermally as received to 5 male and 5 female Sprague Dawley rats had an acute dermal LD50 of greater than 2.0 g/kg. No evidence of systemic toxicity was observed.