2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-03-08 to 2016-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted July 28, 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

EC Number:

500-336-2

EC Name:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

Cas Number:

157348-58-8

Molecular formula:

Exact identification is not feasible

IUPAC Name:

Copolymer of neodecanoic acid oxiranylmethyl ester and phosphorous acid

Test material form:

other: Colourless, viscous liquid

Details on test material:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid manufactured by Evonik Degussa GmbH, Batch 1524201 of 2015-12-22.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS: 
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: female
- Age: approx.4 months
- Weight at study initiation: 3.7 kg - 4.3 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml test item/patch and animal

Duration of treatment / exposure:

4 hour(s)

Observation period:

Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)

Number of animals:

3

Details on study design:

ADMINISTRATION/EXPOSURE
- Preparation of test substance: unchanged
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance,  approx. 6 cm2
- Concentration: 0.5 mL of the test item was applied to the test site (area: approx. 6 cm2).
- Occlusion: gauze patch held in place by semi-occlusive non-irritating  tape dressing
- Inital test:
Three test patches were applied sequentially to the animal. The first patch was removed after three minutes
As no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour.
No skin reactions were observed, neither. So a third patch was applied and removed after 4 hours.
After the end of exposure time, no residual test item had to be removed.
- Confirmatory test:
As no skin reactions were observed in the initial test, the test was completed using two additional animals, each with one patch only, for an exposure period of 4 hours.
- Washing: at the end of the exposure time no residual test item had to be removed.
EXAMINATIONS
- After the 4-hour exposure period the patch was removed and the skin sites were evaluated.
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar  and for edema)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0

Other effects:

no other effects

Any other information on results incl. tables

Findings                                Examination                  Skin irritation scores

of the skin                            schedule                      

animal no.

1             2            3

E/Oe          E/Oe        E/Oe

          500 mL substance/patch/animal

 

erythema and

eschar formations/               before dosing             0/0           0/0          0/0

oedema formation

time after removal after 3 -minute appl (patch 1) 0/0

after 1 hour appl (patch 2) 0/0

after 4 hour exp (patch 3) 0/0

of the patch

(4-hour exposure) patch 3 patch 1 patch 1

60 min                        0/0          0/0          0/0

24 hours                      0/0           0/0          0/0

48 hours                      0/0           0/0          0/0

72 hours                      0/0           0/0          0/0

 

0   no pathological findings    

E   erythema and eschar formations 

Oe  oedema

Applicant's summary and conclusion

Conclusions:

According to the study, the test item showed no irritant effects on the skin of female rabbits.

Executive summary:

The purpose of this study was to examine the test item for acute dermal irritation/corrosion properties in rabbits (patch test).

Under the present test conditions, none of three rabbits exposed for 4 hours to 0.5 mL test item/patch (semi-occlusive conditions) revealed any skin reaction.

There were no systemic intolerance reactions.