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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed
Qualifier:
according to guideline
Guideline:
other: Journal Officiel de la Republique Francaise of 21/4/71 and 5/6/73
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with ethylene glycol
EC Number:
292-932-1
EC Name:
Fatty acids, C16-18, esters with ethylene glycol
Cas Number:
91031-31-1
IUPAC Name:
91031-31-1
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: individually housed in cages or restraining devices which allow the back of the animals to be treated
- Diet: 200 g/day/animal in the form of granules (Granules Lapin Entretien SANDERS)
- Water: ad libitum
- Vaccination: myxomatosis and pasteurellosis

ENVIRONMENTAL CONDITIONS
- air-conditioned

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
other: olive oil
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% (v/v)
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: left flank and right flank (scarified); shaved: 14 cm x 14 cm, patch size: 2 cm x 2 cm
- Type of wrap if used: The treated skin was covered with gauze, held in place with a "NEDDERMOTEST ROC"-patch, and an adhesive tape.

SCORING SYSTEM: Primary irritation index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 h
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:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 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:
Intact skin:
2/6 animals showed slight erythema after 24 h which were fully reversible within 72 h.
Abraded skin:
In 5/6 slight irritating effects were observed after 24 h being fully reversible within 72 h.

No edema formation was apparent in any animal during the study period.
Other effects:
No other local or sytemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study. 

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

1

0

0

0

0

0

1

0

0

0

0

0

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

72 h

0

0

0

0

0

0

0

0

0

0

0

0

 

Table 2. Calculation of mean scores.

 

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value 24 + 48 + 72 h*

0,67

0,00

0,00

0,00

0,00

0,00

0,67

0,00

0,00

0,00

0,00

0,00

*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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified