Registration Dossier

Administrative data

Description of key information

NaTG is considered to be only moderately irritating to the skin. 

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-Mar-2003 - 28-Aug-2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
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)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.6 ± 0.3 kg.
- Food and water: ad libitum
- Acclimation: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- temperature: 18 ± 3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12 h/12 h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Doses of 500 mg of the test item were placed on a water moistened gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals.
Duration of treatment / exposure:
As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals.
Observation period:
The skin was examined approximately 1, 24, 48 and 72 hour(s) after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended.
Number of animals:
3
Irritation parameter:
erythema score
Remarks:
3-minute exposure
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
3-minute exposure
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
4 -hour exposure
Basis:
animal #1
Time point:
other: 24, 48, 72, 96 h
Score:
0
Max. score:
1
Irritation parameter:
edema score
Remarks:
4 -hour exposure
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
4 -hour exposure
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
1
Max. score:
2
Remarks on result:
other: dryness of the skin observed after 48h and 72h
Irritation parameter:
edema score
Remarks:
4 -hour exposure
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Remarks on result:
other: dryness of the skin observed after 48h and 72h
Irritation parameter:
erythema score
Remarks:
4 -hour exposure
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
2
Max. score:
2
Remarks on result:
other: dryness of the skin observed after 48h and 72h
Irritation parameter:
edema score
Remarks:
4 -hour exposure
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Remarks on result:
other: dryness of the skin observed after 48h and 72h
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the experimental conditions, the test item NaTG is 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 or well-defined erythema was noted in all animals on day 1; these reactions

persisted in two of them up to day 5. Dryness of the skin was recorded in 2/3 animals between day 3 and day 5 or 7.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 1.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
07-Mar-2003 - 06-Aug-2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
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)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Breeder: CEGAV, Saint Mars d'Egrenne, France.
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.8 ± 0.2 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:
A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
Duration of treatment / exposure:
continuous
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0.7
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
2.3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
Alopecia around the eye in animal #3.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under our experimental conditions, the test item NaTG 98%, pure is slightly irritant when administered by ocular route to rabbits.
Executive summary:

The objective of this study was to evaluate the potential of the test item NaTG 98%, pure to induce irritation following a single ocular administration in rabbits.

No iritis and no corneal opacity were recorded. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.3 and 2.3 for chemosis, 0.7, 0.3 and 2.0 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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the only mild irritating properties, NaTG should be classified as harmful in contact with skin.

Xi; R21: harmful in contact with skin.

H312: harmful in contact with skin.