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Toxicological information

Skin irritation / corrosion

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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