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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
05 to 19 February 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study undertaken at GLP accredited laboratory to internationally accepted guidelines. The restriction is due to the use of the read across approach: the test was performed not with S-205 but with Black 400, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile .

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
ODB-2
IUPAC Name:
ODB-2
Constituent 2
Reference substance name:
Black 400
IUPAC Name:
Black 400
Constituent 3
Reference substance name:
89331-94-2
EC Number:
618-263-0
Cas Number:
89331-94-2
IUPAC Name:
89331-94-2
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): ODB-2
- Substance type: Colour precursor for heat sensitive record sheets
- Physical state: White powder
- Analytical purity: > 99%
- Lot/batch No.: 61-24101
- Storage condition of test material: Ambient in the dark
- Other: date received: 26 January 1988
- Molecular formula (if other than submission substance): C35 H36 N2 O3
- Molecular weight (if other than submission substance): 532.7
- Smiles notation (if other than submission substance): CCCCN(CCCC)c6ccc5c(Oc2cc(C)c(Nc1ccccc1)cc2C54OC(=O)c3ccccc34)c6
- InChI: InChI=1/C35H36N2O3/c1-4-6-19-37(20-7-5-2)26-17-18-29-33(22-26)39-32-21-24(3)31(36-25-13-9-8-10-14-25)23-30(32)35(29)28-16-12-11-15-27(28)34(38)40-35/h8-18,21-23,36H,4-7,19-20H2,1-3H3

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Seven to 10 weeks.
- Weight at study initiation: 205 to 231 g
- Fasting period before study: no
- Housing: Metal cages with mesh floors.
- Diet: standard laboratory rodent diet, Labsure LAD 1, ad libitum.
- Water: ad libitum
- Acclimation period: At least 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22°C
- Humidity (%): 46%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50mm x 50mm of clipped dorso-lumbar region
- % coverage: 10%
- Type of wrap if used: Gauze held in place with impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Washed with warm water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2mg/kg bw
- Concentration (if solution): 80% w/v paste in distilled water
- Constant volume: yes, 2.5 ml/kg bw
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
2.0 g / kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
A slightly low bodyweight gain was recorded for one female rat on Day 8. Other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalities were found during the autopsy procedure.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats of ODB-2 was found to be: greater than 2.0 g / kg bodyweight.
Executive summary:

S-205 and ODB-2 (Black 400), which is tested for its dermal toxicity, are both colour precursor for heat sensitive record sheets. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that S-205 and ODB-2 have nearly the same chemical structure. The same mode of interaction with bio-macromolecules, living cells and tissue and metabolic pathway is expected. Therefore, a read-across from S-205 to data obtained with ODB-2 is scientifically justified.