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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Study period:
Nov 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
6 animals used, 24 h exposure; no 1 or 48 h reading, no stepwise testing performed, no information on animals or environmental conditions, limited reporting on procedure and results, no information on type of wrap used for patch fixation
GLP compliance:
no
Remarks:
Prior to implementation of GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecan-1-ol, ethoxylated
EC Number:
500-017-8
EC Name:
Octadecan-1-ol, ethoxylated
Cas Number:
9005-00-9
Molecular formula:
not applicable, UVCB
IUPAC Name:
2-octadecoxyethanol

Test animals

Species:
rabbit
Strain:
other: only "albino rabbit" reported
Details on test animals or test system and environmental conditions:
No data.

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: The test material was applied to a shaved area on the back of the animals. Intact skin was exposed on the left half of the shaved area, abraded skin was exposed on the right half of the shaved area. The test material was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed 24 h after administration.
- Type of wrap if used: not specified

OBSERVATION TIME POINTS
24 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
Irritant / corrosive response data:
After test item administration to intact rabbit skin, no skin reactions were observed at any reading time point.
After test item administration to abraded rabbit skin, 2/6 animals showed very slight erythema (score 1) and 1/6 animals showed very slight oedema (score 1).

Any other information on results incl. tables

Table 1: Skin reactions after administration to intact and abraded skin

Parameter Reading time point Rabbit
1 2 3 4 5 6
Erythema 
Intact skin 24 h 0 0 0 0 0 0
72 h  0 0 0 0 0 0
mean 24/48/72h# 0 0 0 0 0 0
Abraded skin 24 h 0 0 0 0 0 0
72 h  1 0 1 0 0 0
mean 24/48/72h# 0.33 0 0.33 0 0 0
Oedema
Intact skin 24 h 0 0 0 0 0 0
72 h  0 0 0 0 0 0
mean 24/48/72h# 0 0 0 0 0 0
Abraded skin 24 h 0 0 0 0 0 0
72 h  0 0 1 0 0 0
mean 24/48/72h# 0 0 0.33 0 0 0
#: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test substance did not induce skin irritation in an in vivo study similar to OECD guideline 404.