2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

Test guideline 2

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

Test material information

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:

other: None

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.