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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
02 Feb - 05 Feb 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no analytical purity reported)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C5-9, tetraesters with pentaerythritol
EC Number:
267-022-2
EC Name:
Fatty acids, C5-9, tetraesters with pentaerythritol
Cas Number:
67762-53-2
IUPAC Name:
67762-53-2
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: not reported
- Lot/batch No.: CRU 98433

Test animals

Species:
rabbit
Strain:
other: Albino Rabbits; New Zealand White, HM: (NZW)fBR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Inc., Hewitt, NJ, USA
- Age at study initiation: at least 8 weeks old
- Weight at study initiation: 2.5 – 2.8 kg
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Lab Rabbit Diet, HF, No. 5325; PMI Feeds, Inc. St. Louis, MO (approx 125 g/day while on test)
- Water: automatic watering system, municipal water supply, ad libitum
- Acclimation period: 60 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: 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
Duration of treatment / exposure:
4 h
Observation period:
3 days
reading time points: 24, 48, and 72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: intact skin of the dorsal trunk surface
- Type of wrap if used: 6 cm² gauze square placed directly on the intact test site per animal and directly held in place with tape. Gauze was then wrapped around the animal and secured with tape to keep the test material in contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was wiped free of test material with 0.9% saline and gauze
- Time after start of exposure: At the end of the exposure period

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 an 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
All three animals showed a very slight or slight erythema 1 hour after the test item application. Within 48 hours after removal of the patches the dermal effect were completely reversible.

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

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