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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl 3,5,5-trimethylhexanoate
EC Number:
275-073-7
EC Name:
2-ethylhexyl 3,5,5-trimethylhexanoate
Cas Number:
70969-70-9
Molecular formula:
C17H34O2
IUPAC Name:
2-ethylhexyl 3,5,5-trimethylhexanoate

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harveys Lake, Pennsylvania.
- Housing: during the test period the animals were individually housed in stainless steel wire bottomed cages in an environmentally controlled room
- Diet (e.g. ad libitum): Purina rabbit pellets ad libitum
- Water (e.g. ad libitum): ad libitum

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

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
other:
Amount / concentration applied:
0.5 g of the test material
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
six healthy rabbits
Details on study design:
Six healthy rabbits were each uniquely identified and then prepared by clipping the trunk free of hair. Two 2.5 cm² square patches were placed under over intact skin and abraded skin on each rabbit. Five-tenths of a milliliter or 0.5 g of the test material was placed under each patch. The entire trunk of the animal was wrapped with a rubberized elastic cloth to retard evaporation and as an aid in maintaining test patch position. Rabbits were placed in neck collars and returned to their individual cages. Collars were removed after 24 hours. All test sites were wiped with a cloth to prevent further exposure. Skin lesions were evaluated at 24 and 72 hours and scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact (left)
Time point:
other: 24 hrs
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: Individual scores not available from report
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact (left)
Time point:
other: 24 hrs
Score:
0
Max. score:
4
Remarks on result:
other: Individual scores not available from report
Irritation parameter:
erythema score
Basis:
mean
Remarks:
abraded(right)
Time point:
other: 24 hrs
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: Individual scores not available from report
Irritation parameter:
edema score
Basis:
mean
Remarks:
abraded(right)
Time point:
other: 24 hrs
Score:
0
Max. score:
4
Remarks on result:
other: Individual scores not available from report
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72hours
Score:
ca. 0.17
Max. score:
8
Remarks on result:
other: Individual scores not available from report
Irritant / corrosive response data:
Test article was found to cause the primary irritation erythema score of 0.33 at 24 hours, but these effects were fully reversible within 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available data, the test article is considered to be a non-primary irritant to the skin.
Executive summary:

The primary skin irritation potential of the test article was investigated. Two 2.5 cm² square patches were placed under over intact skin and abraded skin on each rabbit. Five-tenths of a milliliter or 0.5 g of the test material was placed under each patch. The scoring of skin reactions was performed at 24 and 72 hours after removal of the collars. All test sites were wiped with a cloth to prevent further exposure. Skin lesions were evaluated at 24 and 72 hours and scored.

Under the conditions of this experiment, the test material 2-ethylhexyl 3,5,5-trimethylhexanoate was found to cause a primary irritation score of 0.33 erythema after adiministration of 24 hours when applied to healthy intact and abraded rabbit skin, being fully reversible within 72 hours. Thus, the substance is considered being non-irritant to skin.