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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From July 19 to August 2, 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: standards of AAALAC 16 CFR 1500.3
Principles of method if other than guideline:
Similar to OECD guideline 402 with substancial deviation related to number of animals used.
GLP compliance:
no
Remarks:
pre GLP
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
267-224-0
EC Name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
67827-60-5
Molecular formula:
C31H26N3O6S.Na
IUPAC Name:
sodium 1-amino-4-({3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: at least 8 weeks old when received
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: suspended wire mesh cages (30" x 18" x 18").
- Diet: Fresh Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: 200 square cm
- % coverage: 10 %
- Type of wrap if used: gauze patches

REMOVAL OF TEST SUBSTANCE
- Washing: exposure site washed with warm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg
Duration of exposure:
24 hours
Doses:
2.0 g/kg
No. of animals per sex per dose:
2 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived at a limit dose of 2.0 g/kg
Clinical signs:
other: Very slight edema was noted in all animals at 24 h.

Any other information on results incl. tables

Toxic Signs

All animals appeared normal at all times.

Necropsy Observations

All animals were normal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method:

Standards of AAALAC 16 CFR 1500.3. Similar to OECD guideline 402 with substancial deviation related to the number of animals used.

Observation:

All animals survived this test in good health. Erythema scores could not be determined at 24 hours. All other erythema scores were zero. Very slight edema was noted at 24 hours. All other edema scores were zero. All animals were normal at necropsy.

Results:

LD50 > 2000 mg/kg bw