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: acceptable publication which meets basic scientic principles; basic data on expermimental design are given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA; Nycum, JS
Year:
1962
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 30 (1969), 470
Report Date:
1969
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA
Year:
1962
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 23 (1962), 95
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only 4 animal per group, occlusive wrapping, limited reporting
Principles of method if other than guideline:
pre-guidelien method similar to OECD 402
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
weight at study initiation: 2.5 -3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: part of the trunk
- % coverage: 1/10 of body surface
- Type of wrap if used: impervious plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure:24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): graduate doses were applied, but amount of applied substance was not specified



Duration of exposure:
24 h
Doses:
graduated doses, details not reported
No. of animals per sex per dose:
4, males only
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data
Statistics:
LD50 values calculated by method of THompson (1947, Bacteriol.Rev. 11,115) using the tables of Weil (1952, Biometrics 8, 249). confidence intervals of +/- 1.96 standard deviations are given.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Remarks on result:
other: corresponds to 4353 mg/kg

Any other information on results incl. tables

Fiducial range of LD50 values is not given. Values converted to mg/kg are LD50 > 4353 mg/kg

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
the acute dermal toxicity was > 4353 mg/kg b.w. in male albino New Zealand rabbits.
Executive summary:

the acute dermal toxicity was determined in groups of 4 male albino New Zealand rabbits, each receiving a graduate single dose of test substance followed by 24h occlusive wrapping and 14 d observation. From mortality data the LD50 was calculated as > 5 ml/kg corresponding to > 4353 mg/kg.