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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.12.1984-19.12.1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid methods, however few data were available on test substance composition. Nevertheless it is considered relevant, reliable and adequate for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
EC Number:
939-409-2
Cas Number:
1329-99-3
Molecular formula:
C10H16
IUPAC Name:
Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
Constituent 2
Reference substance name:
Isopropylmethylcyclohexane, tetradehydro derivative
EC Number:
215-532-0
EC Name:
Isopropylmethylcyclohexane, tetradehydro derivative
Cas Number:
1329-99-3
IUPAC Name:
1-isopropyl-4-methylcyclohexane
Test material form:
other: liquid
Details on test material:
The compound Depanol J is a colourless liquid. It was received at C.I.T. on the 23.11.84 in a plastic flask under the reference "Depanol J".
Note by CABB GmbH: handwritten notice of the plant manager, 'Depanol I' misread as 'Depanol J'.
A substance 'Depanol J' was never produced by Hoechst nor by subsequent companies.

Test animals

Species:
rabbit
Strain:
other: Albino New Zealand, Hy / Cr
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Weight at study initiation: 2410 g mean weight
- Housing: Individually in polystyrene cages (0.35 x 0.55 x 0.32 m); each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): Ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Witham, Essex England)
- Water (e.g. ad libitum): Tap water filtered with Millipore filters in water bottles ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50% ± 30%
- Air changes (per hr): No data (The incoming, non-recycled air, was filtered by an absolute filter.)
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 of the back and flanks
- % coverage: Not provided
- Type of wrap if used: The treated area was covered with a hydrophilic gauze patch (Codex) to prevent loss of test material. The test material and the gauze patch were held in contact with the skin with a semi-occlusive patch adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: See under "Any other information on material and methods incl. tables"



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hour
Score:
1.84
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hour
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hour
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: animal found dead day 4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hour
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 hour
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hour
Score:
0.39
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hour
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hour
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: animal found dead day 4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hour
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 48, 72 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hour
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48, 72 hour
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Evaluation of skin reactions

 

Rabbit
No.

D1
1hour

D2
24 hours

D3
48 hours

D4
72 hours

D5

Erythema

01

1

2

2

1

0

02

1

2

2

-

-

03

2

2

2

2

0

04

2

1

1

1

0

05

3

3

2

0

-

06

2

3

3

2

0

Oedema

01

1

1

0

0

0

02

1

1

0

-

-

03

1

1

0

0

0

04

1

0

0

0

0

05

2

1

1

0

-

06

1

1

1

0

0

The animal no. 02 was found dead on Day 4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these experimental conditions and according to the directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
Executive summary:

An acute dermal irritation study was performed with the compound Depanol I in six New-Zealand rabbits, according to the OECD Guideline No. 404 and the OECD Guideline for Good Laboratory Practice.
Erythema and oedema were observed in all animals one hour after instillation (very slight to moderate erythema and very slight to slight oedema). Oedema disappeared from Day 2 to Day 4 and erythema from Day 4 to Day 5.
Under these experimental conditions and according to the Directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.