Trimethyl orthoformate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-11-09 to 1992-11-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

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:

Trimethyl orthoformate

EC Number:

205-745-7

EC Name:

Trimethyl orthoformate

Cas Number:

149-73-5

Molecular formula:

C4H10O3

IUPAC Name:

trimethoxymethane

Details on test material:

- Name of test material (as cited in study report): Trimethylorthoformiat (TMOF)
- Substance type: pure active substance
- Physical state: liquid, colorless
- pH: 5.02
- Water solubility: 10 g/liter
- Analytical purity: 99.8 area-% (method not stated)
- Impurities (identity and concentrations): no data
- Stability under test conditions: Sensitive to hydrolysis
- Storage condition of test material: Closed container, in hood

Test animals

Species:

rabbit

Strain:

other: Kleine Weisse Russen, strain Chbb:HM, SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Kleine Weisse Russen, strain Chbb:HM, SPF
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff K 4 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 1992-11-09 To: 1992-11-13

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume): 0.5 cm3
- Concentration (if solution): undiluted

VEHICLE
- none

Duration of treatment / exposure:

4 hours

Observation period:

30-60 min, 24 h, 48 h, and 72 h after removal of patch

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6cm2
- Type of wrap: gauze patch, held in place with non-irritating tape, semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD Guideline 404: Table: Grading of skin reactions

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals had score 0 at all times

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no erythema or eschar formation at any time

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals had score 0 at all times

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no edema formation at any time

Irritant / corrosive response data:

No signs of dermal irritation were observed 30-60 min after the removal of the patches. Neither were any skin reactions (erythema or edema) found at the later observation time points (24, 48, and 72 hours)

Other effects:

none observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance does not meet GHS classification criteria for skin irritation.