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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary available; Documentation insufficient for assessment of systemic effects

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Principles of method if other than guideline:
Test to study local effects of the test substance on rat skin
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): GP 43692/I
- Physical state: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 126 - 143 g, mean 134 g
- no further data

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Type of coverage:
open
Vehicle:
other: aqueous suspension with Gummi arabicum
Details on exposure:
TEST SITE
- Area of exposure: back, ca. 20 cm2
- Type of wrap if used: open conditions; animals were restrained in small cages during the exposure treatments
- Time intervals for shavings or clipplings: once before the start of the treatment

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 3 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4cm3/animal = ca. 3 cm3/kg bw
- Concentration (if solution): 5%
- Constant volume or concentration used: no data

USE OF RESTRAINERS FOR PREVENTING INGESTION: yes
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
4 weeks; for 3 hours per day
Frequency of treatment:
daily on workdays
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.4cm3/animal = ca. 3 cm3/kg bw
Basis:
other: 5 % aqueous solution with gummi arabicum
Remarks:
Doses / Concentrations:
ca. 150 mg/kg bw/ day
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5
Control animals:
no

Examinations

Observations and examinations performed and frequency:
Effects on skin were recorded 24 hrs after the previous treatment i.e. just before the next treatment; weighing was performed before and at the end of the study; no further information given, however, it can be deduced from the summary of results that resorption effects were also studied.
Sacrifice and pathology:
no data

Results and discussion

Results of examinations

Details on results:
BODY WEIGHT AND WEIGHT GAIN
Mean body weight increased from 134 g on day 0 to 221 g on day 28 (176 - 286 g)

OTHER FINDINGS: LOCAL EFFECTS
no local effects observed

RESORPTIVE EFFECTS
no effects observed (no further data)

Effect levels

open allclose all
Dose descriptor:
NOAEL
Remarks:
local effects
Effect level:
ca. 150 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Highest dose test without local effects
Dose descriptor:
NOAEL
Remarks:
systemic effects
Effect level:
ca. 150 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: only body weight gain was determined; result: normal body weight gain; no details about study observation program

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion