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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.