Registration Dossier

Diss Factsheets

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:
1982
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

Constituent 1
Chemical structure
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

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.