Registration Dossier

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:
Eucalyptus dives, ext.
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.