Registration Dossier
Registration Dossier
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EC number: 421-300-1 | CAS number: 138564-59-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-18 to 1996-04-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Guidelines, Annex V Methods
- Version / remarks:
- (Directive 92/69/EEC of 31 July 1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 421-300-1
- EC Name:
- -
- Cas Number:
- 138564-59-7
- Molecular formula:
- C12H9N3O2S
- IUPAC Name:
- 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- 97.7%
Item code QA405K
Lilly lot no: 356MO1
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 356M01
- Purity test date: March 31, 1995
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in the dark.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Limited, Shaw's Farm, Blackthorn, Bicester, OXP OTP
- Weight at study initiation: 2.16-2.34 kg
- Housing: Individually in aluminium cages (dimensions 48 x 61 x 46 cm) with grid floors beneath which were absorbent paper lined trays. Paper was changed at least once each week.
- Diet (e.g. ad libitum): Standard Rabbit Diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm^2
- Type of wrap if used: Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sterile distilled water was used to remove traces of test material
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48, and 72 h post exposure.
SCORING SYSTEM:
- Method of calculation:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) l
Slight erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema Formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised by more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema or oedema was noted in any of the animals throughout the observation period.
- Other effects:
- The test site was stained yellow in color.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study found that the test substance did not meet the criteria to be classified as a skin irritant according to GHS criteria. The test material was not found to be non-irritant to the rabbit skin.
- Executive summary:
Testing was carried out in accordance with EEC guidelines Annex V and OECD 404. The acute dermal irritation potential of the test material was investigate in 3 New Zealand White rabbits.
The test material was applied as supplied to the shaved dorsal area of the trunk of each rabbit under a semi-occlusive patch which remained in position for 4 h. Skin reactions were then assessed 1, 24, 48 and 72 h after patch removal. No erythema or oedema was noted in any of the animals thoughout the observation period. Yellow colouring of the test sites was noted on Day 1 of the study. Under the conditions of the study, Intermediate 290437 was found to be non-irrtant to rabbit skin.
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