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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given (no details on test substance and test design (type of coverage, exposure duration))

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted Jul 2015
Deviations:
yes
Remarks:
(no details on test substance and test design (type of coverage, exposure duration))
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with diethylene glycol
EC Number:
285-550-1
EC Name:
Fatty acids, C16-18, esters with diethylene glycol
Cas Number:
85116-97-8
Molecular formula:
Not applicable as UVCB
IUPAC Name:
Fatty acids, C16-18, esters with diethylene glycol

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
no data
Observation period:
5 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema (graded with score 1) were observed in all test animals starting 1 h after patch removal which were stable up to the 72 h reading time point. Moreover, slight edema (scored with 2) were determined in 1/3 animals 1 h after application which was still visible as very slight edema (score 1) up to the 72 h reading time point. The remaining animals revealed very slight edema (score 1) at the 1 h reading time point which were reversible 24 h later. Latest on Day 5 after test substance application, the skin reactions were fully reversible.

Any other information on results incl. tables

Table 1. Individual skin reaction scores

Observation time Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
1 h 1 2 1 1 1 1
24 h 1 1 1 0 1 0
48 h 1 1 1 0 1 0
72 h 1 1 1 0 1 0
Mean value 24 + 48 + 72 h 1,00 1,00 1,00 0,00 1,00 0,00
Mean value 24 + 48 + 72 h all animals 1,00 0,33        

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008