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EC number: 203-404-7 | CAS number: 106-50-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- other: raw data related to study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: company guideline previous to OECD guideline implementation that is similar to OECD 404
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Using an electrical shaver the fur of the regio (abdominalis) lateralis of six rabbits (weight: 1.5 – 2kg) was shaved on two neighbouring areas (each 3x3cm). One of the depilated areas was scarificated. 500 mg of the test item mixed with 0.25 ml Propanediol were spread on lobes of 2.5x2.5cm of surgical gauze which were transferred onto the previously prepared skin areas. Using impermeable and indifferent PVC foil (6-8cm wide) the lobules were covered occlusively. Following this the torso of the experimental animals was wrapped with elastic bandages. Treatment time was 24hrs. Animals were examined immediately after exposure (i.e. 24hrs after start of treatment), 48hrs and 72hrs after start of treatment.
- GLP compliance:
- no
- Remarks:
- Performed prior to GLP implementation
Test material
- Reference substance name:
- p-phenylenediamine
- EC Number:
- 203-404-7
- EC Name:
- p-phenylenediamine
- Cas Number:
- 106-50-3
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,4-diamine
- Details on test material:
- - Name of test material (as cited in study report): Nako H (p-Phenylendiamin)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- SPF-Albino-Himalayan rabbit, strain: HIMK (SPFWiga)
rabbits in single cages, feeded with ERKA 8300 of Robert Koch oHG/Hamm and regular water, both offered ad libitum
rabbits weight: 1,5 - 2,0 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved/intact or shaved/abraded
- Vehicle:
- other: Propanediol
- Controls:
- not required
- Amount / concentration applied:
- 500 mg substance, mixed with 0.25 ml Propandiol
- Duration of treatment / exposure:
- duration of treatment: 24 h, without washing
- Observation period:
- examinations were done 24 h, 48 h and 72 h from the beginning of treatment
- Number of animals:
- 6 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: Animal # 14/15/16/17/18/19 (intact skin) each
- Time point:
- other: mean of 24, 48, 72h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no signs of irritation during the entire observation period
- Irritation parameter:
- edema score
- Basis:
- other: Animal # 14/15/16/17/18/19 (intact skin) each
- Time point:
- other: mean of 24, 48, 72h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no signs of irritation during the entire observation period
- Irritant / corrosive response data:
- Scores of the abraded skin are not presented because these data are of no relevance for classification.
- Other effects:
- none during entire study period
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.
- Executive summary:
Nako H (p-Phenylendiamin) was tested for skin irritating or skin corrosive properties according to a company guideline similar to OECD 404. Following these protocol 500 mg of the test substance mixed with 0.25 ml Propanediol were applied to the shaved/intact or shaved/abraded skin of 6 Himalayan rabbits. After 24h exposure time the occlusive covering was removed. In the following 48 h (=72h after beginning of treatment) the animals were periodically examined for signs of skin irritation and or corrosion. Mean scores (mean of 24, 48, and 72h) were calculated for oedema and erythema for each rabbit.
Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.
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