Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 24, 1990 to November 7, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
yes
Remarks:
Due to difficulties in test substance production the initial protocol was replaced by an up to date protocol , study dates were rescheduled and the test substance name was changed in 'Cartasol Blue PE 3562'.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
EC Number:
407-240-9
EC Name:
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
Cas Number:
159604-94-1
Molecular formula:
C66H88Cu2N20O10S2.C3H5O3.C2H3O2
IUPAC Name:
7,7'-bis[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-{μ-4,4'-dihydroxy-1:2k2O4:O4'-3,3'-[3,3'-dihydroxy-1:2k2O3:O3'-biphenyl-bisazo-1:2(N3,N4-η:N3',N4'-η)]dinaphthalene-2-sulphonato(6-)}dicuprate(2-), mixed (1:1) acetic/lactic acid salts
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation:
males: 189 to 219 g
females: 161 to 178 g
- Housing: polycarbonate cages containing purified sawdust as bedding material
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial flourescent light / 12 hours dark per day

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
Water prepared by reverse osmosis
Details on dermal exposure:
TEST SITE
- Area of exposure:
Males: 25 cm2 (5*5 cm)
Females: 18 cm2 ( 3.5*5 cm)
- Type of wrap if used: gauzed patch fixed successively to aluminium foil and flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Concentration (if solution): 2000 mg/kg body weight
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/viability: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
Body weights: Days 1 (pre-administration), 8 and 15
Symptoms: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study period.
Clinical signs:
other: other: There were no signsw of ill health or behavioural changes noted during the obsrevation period.
Body weight:
other body weight observations
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
Other findings:
Treated skin abnormalities: The treated skin area showed in 1 male and 1 female erythema over the first 3 to 4 days. One female was noted with a scab on day 3 only. All animals showed blue staining of the treated skin by the test substance, which had disappeared by day 12 for males and day 13 for females.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 (rat, m/f) > 2000 mg/kg body weight
Executive summary:

The purpose of this study was to assess the toxicity of the test article when administered to rats as a single dermal dose.


The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity' and EEC Directive 84/449/EEC, Part B. 3, "Acute Toxicity - Dermal".


The test item was administered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.


No animals died during the study.


There were no clinical signs of toxicity or behavioural changes noted during the observation period.


All animals showed body weight gain over the study period.


The treated skin area showed in 1 male and 1 female erythema over the first 3 to 4 days. One female was noted with a scab on day 3 only. All animals showed blue staining of the treated skin by the test substance, which had disappeared by day 13.


Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.


The dermal LD50 value of the test item in rats of either sex was established as exceeding 2000 mg/kg body weight.