Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 -`15th November 1988 (experimental phase)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-4-phenylbutan-2-ol
EC Number:
203-074-4
EC Name:
2-methyl-4-phenylbutan-2-ol
Cas Number:
103-05-9
Molecular formula:
C11H16O
IUPAC Name:
2-methyl-4-phenylbutan-2-ol
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Givaudan

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamsted, Herfordshire, UK
- Age at study initiation: 10-12 weeks on arrival
- Weight at study initiation: 2kg
- Housing: individually in grid bottomed metal cages
- Diet: Commerically available antobiotic free rabbit diet (SQC standard rabbit pellets) ad libitum
- Water: Mains drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 5-24°C. Temperature was typically greater than 14°C duing study period.
- Humidity (%): 37-68%
- Photoperiod (hrs dark / hrs light): 12 light/dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hrs and 7 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: Dorsal skin on the trunk clipped free of hair. Left flank and immediately caudal to the last rib.
- % coverage: 6 sq.cm
- Type of wrap if used: Elastoplast elastic adhesive bandage 10cm wide

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated sites cleansed by gentle swabbing with cotton wool soeaked in warm water
- Time after start of exposure: 4 hrs

OBSERVATION TIME POINTS
1, 24, 48, 72 hrs and 7 days

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 3
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0.5
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3
Time point:
24 h
Score:
0.5
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1.5
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Remarks on result:
other: Minimal dequamation
Irritation parameter:
erythema score
Basis:
animal: 3, 4
Time point:
48 h
Score:
1
Irritation parameter:
edema score
Basis:
animal: 1, 4
Time point:
48 h
Score:
0.5
Irritation parameter:
edema score
Basis:
animal: 2, 3
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Remarks on result:
other: Slight desquamation
Irritation parameter:
erythema score
Basis:
animal: 3, 4
Time point:
72 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Irritation parameter:
edema score
Basis:
animal: 2, 3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0.5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a primary dermal irritation study in rabbits, DMPEC was not a skin irritant.
Executive summary:

In a primary dermal irritation study (A/S/12895-12918), 4 female rabbits were dermally exposed (semi-occlusive) to 0.5mL of DMPEC for 4 hours. Animals then were observed for 7 days after dosing. Irritation was scored by the method of Draize.

The average scores calculated from the numerical values given to the irritation observed at the 24, 48 and 72 hour observations were 1.3 for erythema and 0.3 for oedema. Therefore the substance DMPEC is not a skin irritant based on the specific guidance adopted by the UNSCEGHS in June 2011.

This in vivo skin irritation/corrosion study in the rabbit is acceptable and satisfies the guideline requirement for an OECD 404 study.