Registration Dossier
Registration Dossier
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EC number: 208-859-5 | CAS number: 544-10-5
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: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
Test material
- Reference substance name:
- 1-chlorohexane
- EC Number:
- 208-859-5
- EC Name:
- 1-chlorohexane
- Cas Number:
- 544-10-5
- Molecular formula:
- C6H13Cl
- IUPAC Name:
- 1-chlorohexane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.3 kg
- Housing: individually in steel cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03.08.1982 To: 20.08.1982
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 mL undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 17 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6.00 cm2
- Type of wrap if used: linen tissue, polyethylene foil with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with dest. water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- other: eschar formation from day 6-14
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- other: eschar formation from day 6-14
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- other: eschar formation from day 6-14
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: eschar formation from day 6-10
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- other: eschar formation from day 6-14
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Primary irritation score (24,48,72 h):
Erythema: 1.22
Edema: 0.5
In the study report the overall irritation index was 1.73 according to the VCI (Verband der Chemischen Industrie) scheme and thus, the test item was described as slightly irritating. - Other effects:
- Effects were reversible within 17 days. Desquamation was observed from day 6 to day 14.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this skin irritation study in the rabbit the test item was slightly irritating, however not sufficient for classification.
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