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

Body weight:
Significant decreases in bodyweight were observed in treated males on days 2, 7 and 14.
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.