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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Vapor Gard
IUPAC Name:
Vapor Gard
Constituent 2
Chemical structure
Reference substance name:
Oligomerisation products of beta-pinene
EC Number:
701-246-8
Molecular formula:
Variable (dimer = C20-H34)
IUPAC Name:
Oligomerisation products of beta-pinene
Details on test material:
Typical pinene oligomers content 96 wt%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: ranged from 2.3 - 2.6 kg
- Housing: Test animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages were changed twice a week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) provided daily
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hour light / 12 hour dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml per site
Duration of treatment / exposure:
4 hours
Observation period:
Test sites were observed 30-60 minutes, 24h, 48h and 72h after patch removal
Number of animals:
6 animals in total were used in this study (3 male and 3 female).
Details on study design:
The dorsal area of each test animal was clipped free of hair 24 hours prior to the application of the test substance. The clipped area was appoximately 10 sq. cm and the skin remained intact.

Each test site received a dose of 0.5 ml and was applied directly onto the skin. The torso was wrapped with semi-occlusive dressing and secured with a non-irritating tape to hold test patches in position and also to reduce evaporation. The test substance was kept in contact with the skin for 4 hours at which point the wrappings were removed and the test sites washed with distilled water to remove any residual test substance.

Observations for skin reactions were recorded 30 - 60 minutes after removal of wrapping and again at 24, 48 and 72 hours. Erythema and oedema were scored accoring to the Draize technique. Skin was also evaluated for necrosis and ulceration or evidence of tissue destruction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Up to 8 days
Score:
3.58
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
2
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 days
Score:
0.5
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Score 1 for 3/6 animals at last observation time
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
2.17
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
1.83
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 8 days
Score:
0.16
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Single animal showed score 1 at last observation time
Irritant / corrosive response data:
Erythema: well-defined up to 72h, persisting (slight) in 1/6 rabbits at Day 8. All rabbits showed skin flaking at 8 days.
Oedema: slight/well defined at 30-60 mins, well defined to moderate at 24h, slight/well defined at 48 hours, slight at 72h. Single rabbit slight (acore 1) at 8 days.

Any other information on results incl. tables

Overall 6 rabbit mean of 24 + 48 + 72h erythema/eschar scores = 2.0.

3/6 rabbirs showed persistent (score 1) erythema at the last time of observation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Mean 24-48-72h erythema/eschar scores 2.0 and 3/6 cases of persistent erythema Criteria used for interpretation of results: EU
Conclusions:
Applying EU (DSD and CLP) classification criteria, the study results lead to the conclusion irritating to skin.