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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

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