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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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
9 Apr -17 Apr 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study. Lack of test material details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of test material details
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
EC Number:
294-574-1
EC Name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
Cas Number:
91744-13-7
IUPAC Name:
91744-13-7
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Chemical denomination: Glyceride, C14-18 und C16-22-unsatd. mono- und di-
- Physical state: brownish liquid
- Analytical purity: no data
- Lot/batch No.: 0189-0-040

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 19-20 months
- Weight at study initiation: 2770 g
- Housing: animals were housed individually in cages (Heinkel, Kuchen, Germany)
- Diet: Altromin Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with gauze, held in place with an adhesive hypoallergenic tape.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 an 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
After 1h 2/3 animals showed slight erythema being reversible within 24h and 7 days, respectively. After 48 h 1/3 animals showed slight erythema being reversible after 72 h. Edema formation was apparent in 1/3 animals at the 48 and 72 h reading time point and was reversible within 7 days.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

0

0

1

0

1

0

24 h

0

0

0

0

1

0

48 h

1

0

0

0

2

1

72 h

0

0

0

0

1

1

7 days

0

0

0

0

0

0

Mean value 24 + 48 + 72 h

0.3

0.0

0.0

0.0

1.3

0.7

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