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: Non-GLP, guideline-comparable proprietary study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Code of Federal Regulations (Part 191.1)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
No further information
GLP compliance:
no
Remarks:
: study pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material is described as a light yellow powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
New Zealand white albino rabbits in the 1.8-2.3 weight range were used in this study. Two male and two female rabbits were selected.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Two male and two female rabbits had the test substance applied tot he closely clipped, intact abdominal skin beneath a protective binder. After 24 hours, the test material was removed and the abdominal skin inspected for irritation. The test site was washed with water and rewrapped in a gauze binder. The rabbits were monitored for a further 14-day period.
Duration of exposure:
The test substance was applied for 24 hours to intact, clipped skin. The skin was then washed and rewrapped in a gauze binder. The rabbits were then monitored for a further 14 days.
Doses:
The four dose levels used were 1000, 2150, 4540 and 10000 mg/kg bw.
No. of animals per sex per dose:
Two
Control animals:
no
Details on study design:
Four New Zealand white albino rabbits in the 1.8-2.3 weight range were used in this study. Two male and two female rabbits had the test material applied to the abdominal skim beneath a protective binder. After 24 hours, the binder was removed and the abdominal skin inspected for irritation. The test site was then washed with soap and water and rewrapped in a gauze binder. The test animals were observed for a 14 day period following the initial treatment.
Statistics:
None

Results and discussion

Preliminary study:
No preliminary study
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 160 mg/kg bw
95% CL:
2 151 - 4 639
Mortality:
At a dose level of 1000 mg/kg and 2150 mg/kg there was no mortalities. At a dose level of 4640 and 10,000 mg/kg there was 100% mortality.
Clinical signs:
At the 4640 mg/kg dose level the rabbits were observed to be moderately depressed after exposure to the test substance. At the 1000 and 2150 mg/kg dose levels rabbits had mild to moderate necrosis except one rabbit at the 1000 level who was free from irritation. At the 454 mg/kg dose level, one rabbit had slight edema and the remaining three had edema, necrosis and severe erythema.
Body weight:
The body weight was not measured after treatment.
Gross pathology:
No autopsies were performed on the animals.
Other findings:
No further findings.

Any other information on results incl. tables

At the 4640 mg/kg bw dose level the rabbits were observed to be moderately depressed after exposure to the test substance. At the 1000 and 2150 mg/kg bw dose levels, rabbits had mild to moderate necrosis except one rabbit at the 1000 mg/kg bw dose level, which was free from irritation. At the 4540 mg/kg bw dose level, one rabbit had slight oedema and the remaining three had oedema, necrosis and severe erythema.

At dose level of 1000 mg/kg and 2150 mg/kg there were no mortalities. At dose levels of 4640 and 10000 mg/kg bw, there was 100% mortality.

Mortality in the rabbit

Dose level (mg/kg bw)

1000

2150

4640

10000

0/4

0/4

4/4

4/4

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was determined to be 3160 mg/kg bw under the condiitons of this study. Classification for acute dermal toxicity is not required.
Executive summary:

The acute dermal toxicity of phosphorus pentasulphide was investigated in rabbits. The test substance was applied for 24 hours under occlusive conditions at dose levels of 1000, 2150, 4540 and 10000 mg/kg bw. Animals were observed for 14 days.

At the 4640 mg/kg bw dose level the rabbits were observed to be moderately depressed after exposure to the test substance. At the 1000 and 2150 mg/kg bw dose levels, rabbits had mild to moderate necrosis except one rabbit at the 1000 mg/kg bw dose level, which was free from irritation. At the 454 mg/kg bw dose level, one rabbit had slight oedema and the remaining three had oedema, necrosis and severe erythema.

At a dose level of 1000 mg/kg and 2150 mg/kg there were no mortalities. At dose levels of 4640 and 10000 mg/kg bw, there was 100% mortality. The dermal LD50 was calculated to be 3160 mg/kg bw.