2-Propenoic acid, (2,2-dimethyl-1,3-dioxolan-4-yl)methyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline 12 Nousan No. 8147

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

EC Number:

814-155-4

Cas Number:

13188-82-4

Molecular formula:

C9H14O4

IUPAC Name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

Test material form:

liquid

Details on test material:

Analytical study no. 20L00019
Batch: 0812-HS-0030

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Manufacturer, Batch 0812-HS-0030
- Purity: 96.2%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 260g (males), 212g (females)
- Fasting period before study: no
- Housing: single
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40cm² (at least 10% of body surface)
- fur clipped app. 24h before exposure

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.87 ml/kg b.w.

Duration of exposure:

24h

Doses:

2000mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly before application, weekly thereafter
- Necropsy of survivors performed: yes (gross-pathology
- Clinical signs: recorded several times on the day of exposure, daily thereafter
- Other examinations performed:
- scoring of skin findings: 30-60min after removal of the substance, several times thereafter
- mortality: at least once daily

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Other findings:

local effects males:
In all male animals, well-defined erythema (grade 2) was noticed on study day 1 after application, but progressed to moderate to severe erythema (grade 3, from study day 2 until study day 3, 7 or 10. Thereafter, well-defined erythema (grade 2) was observed in one animal from study day 6 until study day 7, while very slight erythema (grade 1) was seen in all animals from study day 8 until study day 10 or from study day 13 until study 14.
Slight edema (grade 2) was seen in all male animals from study day 2 until study day 3, 7 or 10, which regressed in three animals to very slight edema (grade 1) from study day 6 or 8 until study day 10 after application. Incrustations were noticed in four out of five animals from study day 6 until study day 7 or 10. In addition, scaling was seen in four male animals from study day 8 until study day 10 or from study day 13 until study day 14. In one of these animals, erythema and edema beyond the application site were observed from study day 6 until study day 10 after application.

local effects females:
In all female animals, well-defined erythema (grade 2) was noticed from study day 1 until study day 3 and persisted in one of these animals until study day 10 after application, followed by very slight erythema (grade 1) in this female from day 13 until day 14. In the other four female animals, moderate to severe erythema (grade 3) was seen from study day 6 until study day 7 or 10 after application. Thereafter, well-defined erythema (grade 2) was observed from study day 8 until study day 10 in two of these animals, which decreased in one of these animals to very slight erythema from day 13 until day 14. In the other two animals well-defined erythema (grade 2) was observed from study day 13 until study 14. Slight edema (grade 2) was seen in all animals from study day 2 until study day 7 or 10, while in three of these animals very slight edema (grade 1) was observed from study day 8 until study day 10.
In addition, incrustations were noted from study day 2 until study day 14 in two female animals and from study day 6 until study day 7 in another animal. Scaling was noticed in three animals from study day 6 or 8 until study day 10 or 14.
Furthermore, erythema and edema beyond the application area were seen in one animal from study day 6 until study day 10 after application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met