Registration Dossier
Registration Dossier
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EC number: 202-549-3 | CAS number: 96-98-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-nitro-p-toluic acid
- EC Number:
- 202-549-3
- EC Name:
- 3-nitro-p-toluic acid
- Cas Number:
- 96-98-0
- Molecular formula:
- C8H7NO4
- IUPAC Name:
- 4-methyl-3-nitrobenzoic acid
- Details on test material:
- purity: 99.5 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Chbb: NZW (SPF)
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: in fully air-conditioned rooms, separate cages, (arranged in a battery)
- Diet: Altromin 2123 maintenance diet - rabbits, (Altromin GmbH, Lage/Lippe), ad libitum; hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: (volume or weight with unit): 0.5 g Nitro-p-tolylsaure pasted with 0.3 ml isotonic saline - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
2.5 x 2.5 em cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed to
the prepared skin area and then covered with a semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
according to the technique of DRAIZE:
erythema: 0 - 4
edema: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study the test item is not irritating to skin.
- Executive summary:
The substance was tested for skin irritation according to OECD guideline 404.
About 24 hours before the start of the study the hair in the dorsal region of the body of 3 New Zealand albino rabbits was removed with an electric clipper over an area of about 25 cm2 . Only animals with intact skin were used. Each animal was treated with 0.5 g of the substance pasted with 0.3 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE.
No signs of irritation occurred during the whole study
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