Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study follows generally accepted practices. Result (>2 ml/kg) gives clear indication of low toxicity by dermal route.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: This test methodology follows the procedure of the US Federal Hazardous Substances Act (1973) to determine substance toxicity.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: applied as 50% solution in light paraffinic petroleum oil
Details on test material:
50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% light paraffinic petroleum oil

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
Ten healthy mature albino rabbits of New Zealand variety were selected from the stock colony for this study. They were housed in individual
stainless steel cages. Purina Rabbit Chow and water were available ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The compound was applied to the moistened clipped skin of ten rabbits (five intact and
five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off.
Duration of exposure:
24 hour exposure
Doses:
2 ml / kg
No. of animals per sex per dose:
10 (5 abraded and 5 unabraded)
Control animals:
no
Details on study design:
The compound was applied at a dose of 2 ml per kg body weight to the moistened clipped skin of ten rabbits (five intact and
five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off.
The test site was examined for erythema and edema and scores were recorded daily for fourteen days. Body weights were recorded on Days 0 and 14. Rabbits were observed daily for signs of toxicity. All surviving animals were sacrificed at 14 days after treatment and a thorough necropsy was conducted.
Statistics:
Average body weights computed.

Results and discussion

Preliminary study:
Dermal LD50 > 2 ml/kg
Dermal LD0 > 2 ml/kg
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
None.
Body weight:
All animals gained weight during the observation period. See table.
Gross pathology:
No abnormal effects observed.

Any other information on results incl. tables

Body Weights (g)

Animal Skin Day 0 Day 14
1 Abraded 2175 2230
2 Abraded 2370 2410
3 Abraded 2940 2990
4 Abraded 1915 2100
5 Abraded 2810 2885
6 Intact 2425 2510
7 Intact 2270 2340
8 Intact 2390 2465
9 Intact 2800 2895
10 Intact 2630 2720
     
Ave. 2472.5 2554.5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: Guidelines established by the US Federal Hazardous Substances Act (1973)
Conclusions:
The dermal LD0 and LD50 are greater than 2 ml/kg.
Executive summary:

Ten healthy mature albino rabbits of New Zealand variety were selected from the stock colony for this study. They were housed in individual stainless steel cages. Purina Rabbit Chow and water were available ad libitum. The compound was applied at a dose of 2 ml/kg (liquid) to the moistened clipped skin of ten rabbits (five intact and five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off. The test site was examined for erythema and edema and scores were recorded daily for fourteen days. Body weights were recorded on Days 0 and 14. Rabbits were observed daily for signs of toxicity. All surviving animals were sacrificed at 14 days after treatment and a thorough necropsy was conducted.

The rabbits showed no signs of toxicity and no abnormal findings were noted in the necropsy. The dermal LD0 and LD50 are greater than 2 ml/kg.