Registration Dossier

Administrative data

Description of key information

TODI was tested for skin and eye irritation/corrosion properties in studies with rabbits. TODI showed only very slight signs of irritation in eyes and on skin, which were completely reversible within the regular observation periods of the studies. It is concluded that TODI can be regarded as non-irritant to skin and 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:
1997-11-19 to 1997-12-1
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.51 to 2.70 kg
- Housing: individually in supended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20
- Humidity (%): 50 to 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.5 mL


Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
1, 24, 48 and 72 hours following the removal of the patches
Number of animals:
Three (one female, two males)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap: a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm); the trunk was wrapped in a elasticated corset (TURBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minute, 1 hour and 4 hours

OBSERVATION TIME POINTS
1 hour following the removal of patches, and 24, 48 and 72 hours later

SCORING SYSTEM:
- Method of calculation: Draize scoring system (1977)

Irritation parameter:
erythema 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:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
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:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
4-hour exposure period:
No erythema/eschar and oedema observed at observation times >= 24 h. All treated skin sites appeared normal at the 24-hour observation. Very slight erythema (individual score of 1) and very slight oedema (individual score of 1) were noted at two treated skin sites at the 1-hour observation. This effect was fully reversible within 24 hours. No corrosive effects were noted.

3-minute and 1-hour exposure period:
No evidence of skin irritation was noted during the study. No corrosive effects were noted.


Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The test material, TODI, is considerd to be not irritating to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404.

A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produces very slight erythema and very slight oedema at two treated skin sites. All treated skin sites appreared normal at the 24 -, 48- and 72-hour observations. No corrosive effects were noted. 3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit procued no corrosive effects. According to the results, the test material has no irritation and no corrosion potential.

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:
1997-12-11 to 1997-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.68-3.10 kg
- Housing: individual housing
- Diet: free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water: free access to drinking water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 46-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of animals remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL volume (= 67 mg) test material
Duration of treatment / exposure:
one second
Observation period (in vivo):
1 hour, and 24, 48 and 72 hours following treatment
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize, J.H. (1977): Dermal and Eye Toxicity Tests.- In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC, p. 48-49


TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis 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:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Iridial inflammation was confined to one treated eye one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material TODI, was not irritating to rabbits' eye.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/ Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC.

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Transient diffuse corneal opacity to one treated eye at the 24 -hour observation. Transient iridial inflammation was noted in two treated eyes. All eyes appeared normal at the 72 -hour observation.

The test material TODI, was not irritating to rabbits' eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produces very slight erythema and very slight oedema at two treated skin sites. All treated skin sites appreared normal at the 24 -hour observation. No corrosive effects were noted.

In addition: 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit procued no corrosive effects.

Eye irritation

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/ Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Transient diffuse corneal opacity to one treated eye at the 24 -hour observation. Transient iridial inflammation was noted in two treated eyes. All eyes appeared normal at the 72 -hour observation.


Justification for classification or non-classification

The test material is not classified or labelled for skin and eye irritation/corrosion, according to Regulation No (EC) 1272/2008/EC (CLP) based on the available data.