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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979/11/21-1979/12/05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This non-GLP study is similar to current guidelines with deviations that warrant restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 16CFR1500.3
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
2 rather than 5 animals/sex were evaluated for toxicity and the skin of one animal/sex was abraded. Gross necropsy was not performed and minimal detail is provided in the report.
Principles of method if other than guideline:
Four rabbits were dosed at 20 g/kg and exposed dermally for 24 h under gauze dressing as described. If deaths occurred at the initial level, 3 additional groups of 4 rabbits are dosed at log intervals in an attempt to determine the LD 50.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
EC Number:
270-608-0
EC Name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
Cas Number:
68457-79-4
Molecular formula:
{[(iso-C4H9O)0.64(C5H11O)0.36]PS2}2Zn - neutral, {[(iso-C4H9O)0.64(C5H11O)0.36]PS2}6Zn4O - basic
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
Details on test material:
Test material is described as amber liquid with specific gravity of 1.14


Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals supplied by Nicholas Helf were approximately 8 weeks old and weighed between 2.2-2.6 kg when received. The animals were equilibrated to the laboratory for 1 week. Apparently healthy rabbits were selected for the test and identified by cage tags and indelible ear marks. Animals were housed 2/cage in suspended wire mesh cages. Fresh Purina rabbit chow and water were freely available. The animal room was maintained at 20-21°C and kept clean in accordance with AAALAC standards.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Immediately prior to dosing, the fur was clipped from the abdomen of the animals. The clipped area was 200 square cm. Abrasions were made in one half of the rabbits and extended the length of the exposure site. The abrasions scratched the stratum corneum but did not reach the derma or produce bleeding. Test material was applied once dermally under gauze patches, secured with adhesive tape, and wrapped around the trunks with an impervious material.

Duration of exposure:
Test material was held in contact with the skin for 24 h, at which time the wrappings were removed. The exposure site was wiped, but not washed, to remove any excess material.

Doses:
20 g/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
Dermal reactions were scored at 24 h by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in the survivors at 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mL/kg bw
Mortality:
All animals survived the test.
Clinical signs:
other: Lethargy, diarrhea, ataxia, ptosis, alopecia, emaciation, yellow nasal discharge and sensitivity to touch were noted during the second week of observation. Well defined erythema and slight edema were noted at 24 h.
Gross pathology:
No data.
Other findings:
No data.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test article, when administered dermally as received to 2 male and 2 female New Zealand white rabbits had an acute dermal LD50 of greater than 20.0 g/kg
Executive summary:

In an acute dermal toxicity study, New Zealand White rabbits were exposed to 20 g/kg of the test substance. The LD50 on Day 14 post-exposure was greater than 20 g/kg. Toxic signs observed included lethargy, diarrhea, ataxia, ptosis, alopecia, emaciation, and yellow nasal discharge. Based on the results of this study, the test substance would not be classified in accordance with the classification system of GHS. This toxicity study is classified as acceptable and satisfies the guideline requirement for acute dermal toxicity in rabbits.