Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted non-GLP, with limited data on study design, however the study was conducted according to state of the art methods at that time period. The study is considered adequate, reliable and relevant.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Surfactant E-196 (80% active)
- Physical state: Not provided, however it is assumed to be a visous liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided


Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
Not provided

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: Not provided
- % coverage: Not provided
- Type of wrap if used: an impervious cuff

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not provided
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 g/kg (an aqueous paste of the product)
- Constant volume or concentration used: yes
- For solids, paste formed: yes


Duration of exposure:
24 hours
Doses:
5.0 g/kg aqueous paste of Surfactant E-196 (80% active)
No. of animals per sex per dose:
10 male rabbits
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequency of observations not provided; Initial and
Terminal weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not provided

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
act. ingr.
Mortality:
1/10 animals died on the sixth day after dosing.
Clinical signs:
Hind leg weakness
Body weight:
Initial mean body weight was 2.84 kg. Terminal mean body weight was 2.75 kg.
Gross pathology:
Gross pathology of the survivors was normal.

Any other information on results incl. tables

Table1. Single dermal dose in male albino rabbits

             An aqueous paste of the product was held under an impervious cuff in continuous 24-hour

             contact with the shaved skin.

Dosage

Onset of (S) Signs, (D) Death, Hours and Days

DIED

Mean Wt.

Time of (R) Recovery, Days

DOSED

0-6

6-24

2

3

4

5

6

7

8-14

 

I

T

1

2

3

4

5

6

7-14

 5.0 g/kg

 

 

 

S

 

 

D1

 

 

1/10

2.84

2.75

 

 

 

 

 

 

R

  LD50 greater than 5.0 g/kg

Signs of intoxication: Hind leg weakness.

Skin irritation: Severe erythema and severe edema followed by eschar formation.

Gross autopsy: Survivors-normal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This test item is considered to be pratically non-toxic by single skin application.
Executive summary:

Acute dermal toxicity was tested in 10 male albino rabbits under covered application to the clipped skin of 5.0 g Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt (80% active ). There was one mortality at day 6 and weakness of the hind legs was seen in one animal. The survivors showed no gross pathology at autopsy.There was a severe erythema and severe edema followed by eschar formation. Dermal LD50 was >5000 mg/kg bw. Taking into account that the product contained 80% active ingredient, the LD50 corresponds with >4000 mg active ingredient/kg bw.

This test item is considered to be practically non-toxic by single skin application.