2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

08 July 2003 - 18 July 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD test guidance in compliance with GLP and reported with a valid GLP certificate. The study is read across to an analogous substance; refer to image and further information below.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Annex V

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

144971-11-9

Cas Number:

144971-11-9

IUPAC Name:

144971-11-9

Test material form:

liquid: viscous

Details on test material:

CAS Number: 144971-11-9
Description: Clear colourless liquid
Batch: D21287
Purity: >97.3%
Test substance storage: At room temperature in the dark
Stabilty under storage conditions: Not indicated
Expiry date: 01 September 2003

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD). Source: Charles River Deutschland, Kisslegg, GermanyNo. of animals: 3 Males.Age and bodyweight: Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.Identification: Earmark.ConditionsAnimals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0:! 3.0°C (actual range: 16.1 - 23.0°C), a relative humidity of 30-70% (actual range: 43 -79%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relativehumidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.AccommodationIndividually in labelled cages with perforated floors (Scan bur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.DietStandard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, pressed hay (BMI, Helmond, the Netherlands) was provided twice a week.WaterFree access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

All available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no severe effects were to be expected. An in-vitro skin irritation test was considered, but no validated test was found available. Therefore, this in-vivo skin irritation study was started bytreatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 7 days later, after considering the degree of skin irritation observed in the first animal.Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, tofaciltate scoring..A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.Each animal was treated by dermal application of 0.5 ml of the test substance. The test substance was applied to the skin of one flank, using a metallne patch' of 2x3 cm. The patch was mounted on Micropore tape', which was wrapped around the abdomen and secured with Coban elastic bandage'. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.Observations:Mortaliy/ Viabilty Twice daily.Toxicity: At least once daily.Body Weight: Day of treatment (prior to application) and at termination.Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Max. score:

1

Remarks on result:

other: Max. duration: 1 d; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Max. score:

1

Remarks on result:

other: Max. duration: 2 d; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Four hours exposure to 0.5 ml of HATCOL 3331 resulted in very slight erythema and/or very slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 24 hours in two animals and within 48 hours In the other animal.

Other effects:

CorrosionThere was no evidence of a corrosive effect on the skin.ColourationNo staining of the treated skin by the test substance was observed. Sticky remnants of the test substance were present on the edges of the treated skin area on day 1.Toxicity I MortalityNo symptoms of systemic toxicity were observed in the animals during the test period and no mortaliy occurred.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Read across to structural analogue. Structural details are listed above. Based on the results and according to the EC criteria for classification and labelling requirements, HATCOL 3331 does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

Read across to structural analogue. Structural details are listed above. Based on the results and according to the EC criteria for classification and labelling requirements, HATCOL 3331 does not have to be classified and has no obligatory labelling requirement for skin irritation.