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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: ECHA provided robust study summary

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
-
EC Number:
444-010-7
EC Name:
-
Cas Number:
82654-98-6
Molecular formula:
C12H18O3
IUPAC Name:
4-(butoxymethyl)-2-methoxyphenol

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - 3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 21 day
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 21 days
Other effects:
Scaliness was observed after 7 days, this resolved within 21 days and was considered to be a reversible skin reaction.

Applicant's summary and conclusion

Interpretation of results:
other: not classified Migrated information
Remarks:
Criteria used for interpretation of results:EU
Conclusions:
The primary skin irritation/corrosion study with the test item in the rabbit revealed no irreversible effects.
Executive summary:

The primary skin irritation/corrosion study with the test item in the rabbit (4-hour semi-occlusive application) was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation". Three rabbits were exposed to 500g of the test item, applied onto skin for 4 hours using a semi-occlusive dressing. Observations were made 24, 48 and 72 hours after exposure. Exposure resulted in well-defined erythema and very slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Erythema at the edges of the application-area and scaliness were observed 72 hours and/or 7 days after exposure. The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.