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Diss Factsheets

Administrative data

Description of key information

DADTDG did not show irritating effects when applied to rabbit skin for 4min or 4h, and was non to slightly irritating to rabbit eyes, while the effects were fully reversible. Therfore, the substance does not need to be classified as skin or eye irritant according to GHS criteria.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Reg 92/69EEC B.4 (1992-07-31)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.4 ± 0.1 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France) ad libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period:at least 5 days


ENVIRONMENTAL CONDITIONS
- 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:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 48.1 % active substance
Duration of treatment / exposure:
3 min/ 4 h
Observation period:
Skin was examined after appr. 1 h, 24, 48 and 72 h after removel of the dressing
No cutaneous reactions were observed during the study.
Number of animals:
3 animals/group
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
4h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test material diammonium 2,2'-dithiodiacetate is not irritating when applied to rabbits.

Classification: not irritating
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Reg 92/69/EEC B.5 (1992-07-31)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation:  2-4 months
- Weight at study initiation: 2.7+/-0.2 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay sur Orge, France) ad  libitum
- Water (e.g. ad libitum): filtered drinking 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:
Test material: Diammonium 2,2'-dithiodiacetate 48% in water
one single dose of 0.1 ml test material (undiluted) was administered.
All animals sceamed just after the treatment.
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:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

none to very slight conjunctival reactions including a very slight chemiosis grade 1 a very slight redness (1 -2) are observed in day one and 2 for 2 animals. No other ocular reactions were observered during the study. Mean scores for rednes and chemusis are 0.3 only for day one.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item diammonium 2,2'-dithiodiacetate is not or very slightly irritant when administrated by ocular route to rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
OECD TG and GLP-Study

Justification for selection of eye irritation endpoint:
OECD TG and GLP-Study

Justification for classification or non-classification

According to the GHS classification criteria, the test item should not be classified as irritating to the eyes or the skin.