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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good scientific study with appropriate reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pigs are exposed to the test chemical for 6 hours after which skin irritation is assessed after 24 and 48 hours.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Eucalyptus dives, ext.
EC Number:
289-839-3
EC Name:
Eucalyptus dives, ext.
Cas Number:
90028-48-1
Molecular formula:
not applicable - UVCB
IUPAC Name:
(5R)-2-methyl-5-(propan-2-yl)cyclohexa-1,3-diene; (6R)-3-methyl-6-(propan-2-yl)cyclohex-2-en-1-one
Test material form:
other: liquid

Test animals

Species:
guinea pig
Strain:
Hartley
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 404-577 g
- Housing: individually housed in wire mesh cages.
- Diet (e.g. ad libitum): Purine guine pig chow given ad libitum throughout quarantine and test periods.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Diethyl phthalate
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5, 1, 2.5 or 5% w/v or 10, 25, 50 or 100% w/v

Duration of treatment / exposure:
6 hours
Observation period:
24 hours
Number of animals:
4 (2 male and female)
Details on study design:
TEST SITE
- Area of exposure: animal's back
- Type of wrap if used: occluded patch with rubber dental dam pulled taut with clips

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material removed by an apporpriate solvent
- Time after start of exposure: 6 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 0.75
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: 0.5%; slight patchy erythema seen in 3/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 0.75
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: 1%; slight patchy erythema seen in 3/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: 2.5%; slight patchy erythema seen in 4/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: 5%;slight patchy erythema seen in 4/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 0.5
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: 10%; slight patchy erythema seen in 2/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 1
Reversibility:
not fully reversible within: 48 hr
Remarks on result:
other: 25%; slight patchy erythema seen in 3/4 animals and moderate erythema in 1 animal
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 1
Reversibility:
not fully reversible within: 48 hr
Remarks on result:
other: 50%; slight patchy erythema seen in 4/4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 1
Reversibility:
not fully reversible within: 48 hr
Remarks on result:
other: 100%; slight or moderate patch erythema in 4/4 animals
Irritant / corrosive response data:
0.5-5% w/v caused no effects at 24 or 48 hours.
10% w/v caused irritation in 2/4 animals at 24 and 48 hours. No effects were seen in 2/4 animals.
25 and 50% w/v asued some irritation at 24 and 48 hours in 4/4 animals.
100% w/v (undiluted) caused irritation in 4/4 animals at 24 and 48 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the slight irritation seen at lower concentrations, the chemical is considered to cause irritatint effects. Following Regulation (EC) 1272/2008, the substance is classified as slightly irritating.