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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 11 - 14, 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recognised guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-4-(trifluoromethyl)pyridine
EC Number:
606-870-3
Cas Number:
219715-34-1
Molecular formula:
C7H6F3NO
IUPAC Name:
2-methoxy-4-(trifluoromethyl)pyridine
Details on test material:
- Name of test material (as cited in study report): M-TMP
- Physical state: colourless liquid
- Analytical purity: 99.7%
- Lot/batch No.: 041206-7D
- Expiration date of the lot/batch: n/a
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: room temperature
- pH: 6-7 (by wetted pH paper)
- Solubility: Soluble in methanol, ethanol, and acetone.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Received from Robinson Services, Inc. Gammons, NC on December 29, 2004.
- Age at study initiation: Young adult.
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed eneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Certified Rabbit Diet PMI #5322
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 55-62%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a milliliter of the test substance was applied
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 intact dose site
- Type of wrap if used: Each animal was covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they wore returned to their designated cages.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The pads and collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure

SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system:

Evaluation of Skin Reactions Value

Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect noted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects noted
Irritant / corrosive response data:
Within 24 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation within 72 hours.
Other effects:
One animal exhibited soft feces on Day 3. The other two animals appeared active and healthy during the entire observation period.

Any other information on results incl. tables

TABLE 1: INDIVIDUAL SKIN IRRITATION SCORES

ERYTHEMA/EDEMA

Animal No. Sex Hours After Patch Removal
1 24 48 72
13481 M 2/1 2/1 2/13 0/03
13482 M 2/1 2/1 1/13 0/03
13483 M 2/1 1/1 1/03 0/03
Total 6/3 5/3 4/2 0/0
Mean 2.0/1.0 1.7/1.0 1.3/0.7 0.0/0.0

3 Desquamination noted

TABLE 2: SUMMARY OF PRIMARY SKIN IRRITATION SCORES4

  Hours
1 24 48 72
Erythema 2.0 1.7 1.3 0
Edema 1.0 1 0.7 0
TOTAL (PDI)5 3.0 2.7 2.0 0

4 Average values for three rabbits.

5 PDI= Average Erythema + Average Edema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, M-TMP caused very slight to well-defined erythema and very slight edema which cleared by 72 hours.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for M-TMP to produce irritation after a single topical application. Under the conditions of this study, the test substance caused very slight to well-defined erythema and very slight edema which cleared by 72 hours.

Five-tenths of a milliliter of the test substance was applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.

Within 24 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation within 72 hours,