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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Toxicity: dermal

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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: Comparable to guideline study with acceptable restrictions (TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
EC Number:
226-106-9
EC Name:
N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Cas Number:
5280-78-4
Molecular formula:
C40H23Cl5N6O4
IUPAC Name:
N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
Test material form:
solid: bulk
Details on test material:
- Physical state: red powder
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 * (body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water

TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after 25 hours, 7 and 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abrasion (2/4 animals) had no effect on local or systemic effects
Mortality:
no mortality
Clinical signs:
other: in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; Anorexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.
Gross pathology:
One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal findings in the other two animals (with abraded skin).
Other findings:
Neither erythema nor edema were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information