Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently documented. Basic data given: comparable to guidelines/standards. Test substance purity is 65%.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
See confidential details on test material section

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BASF
- Weight at study initiation: mean: male and female = 2.4 kg
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
The product was administered in various dosages as a 50% aqueous dispersion processes once to the shaved skin.
Duration of exposure:
24 hours
Doses:
1000, 2000, 4000 mg/kg bw
No. of animals per sex per dose:
4000 mg/kg: 4 males and 2 females; 2000 mg/kg: 1 male and 2 females; 1000 mg/kg: 2 males and 1 female
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
Statistics:
no data available

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Based on:
test mat.
Remarks:
(equivalent to the substance as registered)
Mortality:
4000 mg/kg: 3 males and 1 female died between 48 hours and day 14.
2000 and 1000 mg/kg: all animals survived
Clinical signs:
4000 mg/kg: Apathy, weight loss, reduced food intake were observed. No clinical signs in the surviving animals after 3-4 days.
2000 and 1000 mg/kg: No clinical signs observed.
Body weight:
no data available
Gross pathology:
Deceased animal: Petechiae on the mucous membranes of the stomach in 3/4 rabbits at 4000 mg/kg.
Other findings:
no data available

Any other information on results incl. tables

Table: results

Doses

mg/kg

Concentration

%

N° of animals

mortality

1 hour

24 hours

48 hours

7 days

14 days

4000

50

4 males

2 females

0/4

0/2

0/4

0/2

2/4

1/2

3/4

1/2

3/4

1/2

2000

50

1 male

2 females

0/1

0/2

0/1

0/2

0/1

0/2

0/1

0/2

0/1

0/2

1000

50

2 males

1 female

0/2

0/1

0/2

0/1

0/2

0/1

0/2

0/1

0/2

0/1

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study, the dermal LD50 of Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda was ca. 3000 mg/kg in rabbits.
Executive summary:

The substance has been tested for acute dermal toxicity in rabbits, according to a method similar to O.E.C.D. guideline Nb.402. The test article was applied as a 50% aqueous dispersion to groups of male and female rabbits at doses of 1000, 2000 and 4000 mg/kg bw, respectively for 24 hours. At the end of the period of exposure, the animals were examined for 14 days.

At 4000 mg/kg, 3 males and 1 female died between 48 hours and day 14. Apathy, weight loss, reduced food intake were observed. No clinical signs were observed in the surviving animals after 3-4 days. At 2000 and 1000 mg/kg, all animals survived. No clinical signs were observed.

As the acute dermal LD50 was calculated as ca. 3000 mg/kg under the conditions of the test, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is not classified according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/CEE.