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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:
documentation insufficient for assessment
Remarks:
Only short summary available

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]
EC Number:
226-999-5
EC Name:
3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]
Cas Number:
5590-18-1
Molecular formula:
C22H6Cl8N4O2
IUPAC Name:
3,3'-(1,4-phenylenediimino)bis(4,5,6,7-tetrachloro-1H-isoindol-1-one)
Constituent 2
Chemical structure
Reference substance name:
mono/bis-methoxy derivatives
Molecular formula:
C22-24H6-12Cl6-8N4O2-4
IUPAC Name:
mono/bis-methoxy derivatives
Test material form:
solid: bulk
Specific details on test material used for the study:
- 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 or test system 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): 0.4cm^3/animal (= ca. 3 cm^3/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 5 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0.4 other: cm^3/animal
Remarks:
5 % aqueous solution with gummi arabicum
Dose / conc.:
150 mg/kg bw/day
Remarks:
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

Clinical signs:
not specified
Dermal irritation:
no effects observed
Description (incidence and severity):
Local effects: no effects observed
Resorptive effects: no effects observed (no further data)
Mortality:
not specified
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Mean body weight increased from 134 g on day 0 to 221 g on day 28 (176 - 286 g)
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Endocrine findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

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