Registration Dossier
Registration Dossier
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EC number: 218-267-9 | CAS number: 2100-42-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976-11-22 to 1976-11-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- other: raw data related to study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
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. Lobes of 2.5x2.5cm of surgical gauze were soaked with 0.5mL of undiluted liquid test substance and 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. Application 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:
- 1-chloro-2,5-dimethoxybenzene
- EC Number:
- 218-267-9
- EC Name:
- 1-chloro-2,5-dimethoxybenzene
- Cas Number:
- 2100-42-7
- Molecular formula:
- C8H9ClO2
- IUPAC Name:
- 2-chloro-1,4-dimethoxybenzene
- Details on test material:
- - Name of test material (as cited in study report): CME = Chlorhydrochinondimethyläther (2-Chlor-1,4-dimethoxybenzol)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- - SPF-Albino-Himalayan-rabbits (strain HOE:HIMK(SPFWiga)) were used as experimental animals
- Animals were kept in single cages
- Food (ERKA 8300, company: Futtermittelwerke Robert Koch oHG, Hamm) and tap water were supplied ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved/intact or shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5mL of undiluted liquid test substance
- Duration of treatment / exposure:
- 24hrs of exposure wihout washing
- Observation period:
- The observation period lasted 72hrs from the beginning of exposure.
- Number of animals:
- 6 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #83
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #82
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #85
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #84
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #86
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animal #87
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #83
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #82
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.7
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #85
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #84
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #86
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Reversibility:
- other: effects were fully reversible within 72h
- Irritation parameter:
- edema score
- Basis:
- other: mean of animal #87
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Reversibility:
- other: effects were fully reversible within 72h
- Irritant / corrosive response data:
- erythema score (mean of 24, 48 and 72 h)
Animal #: 83/82/85/84/86/87 (intact skin):
0.3/0.3/0.3/0.7/0.7/0.7
oedema score (mean of 24, 48 and 72 h)
Animal #: 83/82/85/84/86/87 (intact skin):
1.0/1.7/1.0/1.0/1.3/1.3
effect were fully reversible wihin 72h
Scores of the abraded skin are not presented because these date are of no relevance for classification.
Any other information on results incl. tables
.
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:
CME was tested for skin irritanting or skin corrosive properties according a company guideline similar to OECD 404. Following these protocol 0.5 ml of the undiluted test substance was applied to the shaved/intakt or shaved/abraded skin of 6 Himalayan rabbits. After 24 h exposure time the occlusive covering was removed. In the following 48h (=72h after beginning of treatment) the animals were periodically examined for signs of skin irritation and or corrosion. Mean scores (mean of 24, 48, 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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