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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1990-03-29 - 1990-04-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The GLP study was conducted according to an internationally accepted guideline. All study parameters are given in detail.Nevertheless, according to the ECHA's practical guide 6: "How to report read-across and categories" the maximum for read-cross is 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): NISSEKI-SAS-40 (Mixture of benzyl-toluene and diphenyl ethan)
- Molecular formula (if other than submission substance): C14 H14
- Molecular weight (if other than submission substance): 182.27
- Structural formula attached as image file (if other than submission substance): see 'attached background material'
- Substance type: organic
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
The animal room was maintained at a temperature of 20 - 24°C and relative humidity of 40 - 56%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately twenty-four hours prior to the commencement of the test the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 5 cm x 4 cm.

The calculated volume of the undiluted test material, as received, was applied uniformly to an area of shorn skin approximating to 10% of the total body surface area using a graduated syringe. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage (HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were housed individually during the exposure period.

Shortly after dosing the dressings were checked. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were then returned to group housing.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
All animals were observed for overt signs of toxicity and death 1 and 4 hours after dosing and subsequently at least once daily for fourteen days.

Individual bodyweights were recorded on the day of treatment (day 0) and on days seven and fourteen.

All animals were subjected to a gross necropsy examination for any macroscopic abnormalities. No tissues were retained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No evidence of systemic toxicity or skin irritation were noted during the study.
Body weight:
Individual bodyweights, together with weekly bodyweight gains, are given in Table 2.

All animals showed expected gain in bodyweight during the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study.

Any other information on results incl. tables

For category rationale and justification see attached category documentation under section 13 "Assessment Reports".

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, NISSEKI - SAS -40, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity" referenced as Method B3 in Annex V of EEC Commission Directive 84/449/EEC.

A group of ten animals (five males and five females), was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin, at a dose level of 2000 mg/kg bodyweight.

There were no deaths. No evidence of systemic toxicity or skin irritation were noted during the study.

All animals showed expected gain in bodyweight during the study period.

No abnormalities were noted at necropsy of animals killed at the end of the study.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg body- weight.