Registration Dossier

Administrative data

Description of key information

MeaTG is not irritating to the skin and the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-03-2003 - 06-08-2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.5 ± 0.2 kg
- Food and water: ad libitum
Environmental conditions:
- Acclimation period:at least 5 days
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 min, 4 h
Observation period:
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Since there was persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 6).
Number of animals:
3
Irritation parameter:
erythema score
Remarks:
3-minute exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
3-minute exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
4 -hour exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: Day 4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: Day 6
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Dryness of the skin at day 6
Interpretation of results:
GHS criteria not met
Conclusions:
Under experimental conditions, the test item MEATG 83% is slightly irritant when applied topically to rabbits.
Executive summary:

After a 3-minute exposure (one animal), no cutaneous reactions were observed.

After a 4-hour exposure (three animals), a very slight erythema (grade 1) was noted in all animals on day 1 and persisted in two of them until day 4 (one animal) or day 6 (one animal). Dryness of the skin was recorded in 1/3 animals between on day 6.

Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-03-07 - 2003-08-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation:  2-4 months
- Weight at study initiation: 2.8 +/-0.3 kg
- Food and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
continuous
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: Day 3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: Day 3
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: Day 3
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: Day 3
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the test item MEATG 83% is very slightl irritant when administered to eyes of rabbits.
Executive summary:

The objective of this study was to evaluate the potential of the test item MEATG 83% to induce irritation following a single ocular administration in rabbits.

Very slight or slight conjunctival reactions, consisting of a very slight chemosis (grade 1), a very slight or slight redness of the conjunctiva (grade 1 or 2) and a clear discharge, were observed in all animals on days 1 and 2. No other ocular reactions were recorded during the study.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.0 and 0.0 for chemosis, 0.3, 0.3 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on only slightly irritating properties, MEATG 83% should not be classified as harmful or toxic in contact with skin or the eyes.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Conclusive, but not sufficient for classification.