Registration Dossier

Administrative data

Description of key information

Skin irritation:

In a GLP compliant K1 in vivo skin irritation study in New Zealand White Rabbits according to OECD Guideline 404 and EU Method B.4, T002907 was not irritating to the skin based on the criteria of the CLP Regulation (EC) No 1272/2008.

 

Eye Irritation:

In a K1 in vivo eye irritation/corrosion study in New Zealand White Rabbits according to OECD guideline 405 and EU Method B.5, T002907 should not be classified for eye irritation or serious eye damage based on the criteria of the CLP regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-05-12 to 2005-05-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well-documented, GLP compliant study, performed in accordance with OECD Guideline 404 and Commission Directive 2004/73/EC, B.4. No major deviations were recorded.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 06C0828
- Expiration date of the lot/batch: 2007-03-31 (retest date)
- Purity: 99.9%
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 +/- 5°C), light protected
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was weighed as delivered by the sponsor and then moistened with approximately 0.5 mL of purified water before application.
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: young adult New Zealand White rabbit (SPF), from Harlan France, ZI Le Marlcourlet, 03800 Gannat/France
- Age at treatment: 11 weeks (male), 11-12 weeks (females)
- Weight at first day of acclimatization: 2404 grams (male), 2157-2262 grams (females)
- Housing: standard laboratory conditions, in air-conditoned rooms, individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing. Music was played during the daytime light period.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 5 days (2006-05-12 to 2006-05-16), under laboratory conditions after health examinations. Only animals without any visual signs were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 2006-05-17 To: 2006-05-22
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): 500 mg
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left flank, ca. 4cm x 4cm
- % coverage: no data
- Type of wrap if used: the dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing, the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item).
- To allow further examination of the test site animal No. 51 was re-clipped on completion of the 24-hour examination.

SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the commission Directive 2004/73/EC, April 29,2004. If evident, corrosive or staining properties of the test item were described and recorded.
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 49 (male)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 50 (female)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 51 (female)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 49 (male)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 50 (female)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 51 (female)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. No staining produced by the test item of the treated skin was observed. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of the animals were considered to be within the normal range of variability.
Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001) and the criteria laid down by the CLP regulation, TIC2782 (T002907) is considered to be “not irritating” to skin.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004-04-15 to 2004-04-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was performed following the OECD Guideline 404 and EU Method B4 of Commission Directive 92/69/EEC, but not in compliance with GLP. Limited information on test system and test article available.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. No formal claim of GLP compliance is made for this study.
Specific details on test material used for the study:
no data
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: 3 male New Zealand White rabbits, no further details on animals

ENVIRONMENTAL CONDITIONS
- Temperature (°C):no data
- Humidity (%):no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):no data
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure:no data
- % coverage:no data
- Type of wrap if used:no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done):no data
- Time after start of exposure:no data

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after administration

SCORING SYSTEM:
- according to Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 140 (male)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 141 (male)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal no. 131 (male)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 140
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 141
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal no. 131
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 24-hour observation.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the experiment, the test item T002907 is not considered to be a skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-10-05 to 2005-10-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented study performed according to OECD and EC guidelines, in compliance with GLP. No deviation noted.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00467090 (=charge 05C0836)
- Expiration date of the lot/batch: 2006-05-04
- Purity: 99.9%
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 +/- 5°C), light protected
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted as it was delivered by the sponsor.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 1 male and 2 female young adult New Zealand White rabbits, SPF; Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany
- Age at treatment: 11-12 weeks (male), 10-12 weeks (females)
- Weight at first day of acclimatization: 2206 grams (male), 1811 - 1821 grams (females)
- Housing: Standard Laboratory Conditions; individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 42/05, Provimi Kliba AG) were provided for gnawing.
- Diet (e.g. ad libitum): ad libitum, pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): ad libitum, community tap water from Füllinsdorf
- Acclimation period: at least 5 days, under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.

IN-LIFE DATES: From: 2005-10-10 (one female), 2005-10-11 (one male and one female) To: 2005-10-14
Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal

VEHICLE
- No vehicle used.
Duration of treatment / exposure:
single dosing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
one male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
- The ocular reaction (i.e. corneal opacity, iridic effects, conjunctivae and chemosis) was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, at approximately 1, 24, 48 and 72 hours after instillation.
- Additionally, ocular discharge, reddening of the sclerae and staining of conjunctivae, sclerae and cornea by the test item was assessed.
- When present, corrosion was recorded and reported.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach, Switzerland)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
IRRITATION:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.00 for reddening and 0.00, 0.33 and 0.00 for chemosis, respectively.
- No abnormal findings were observed in the iris of any animal at any of the measurement intervals.
- Very slight corneal opacity affecting the whole area was noted in one animal at the 1-hour reading.
- Slight to moderate reddening of the conjunctivae was noted in all animals one hour after treatment and persisted as slight reddening in one animal at the 24-hour reading.
- Slight swelling (chemosis) of the conjunctivae was observed in one animal at the 1- and 24-hour reading.
- Slight reddening of the sclerae was present in all animals one hour after treatment and persisted as slight reddening in one animal at the 24-hour reading.
- No abnormal findings were observed in the treated eye of any animal 48 hours after treatment.

CORROSION:
- No corrosion of the cornea was observed at any of the reading times.
Other effects:
- Viability/mortality: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Coloration: no staining of the treated eyes produced by the test item was observed.
- Body weights: the body weights of all rabbits were considered to be within the normal range of variability.
Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), TIC2782 (T002907) is considered to be “not irritating” to the rabbit eye. The test item is considered not to be classified based on CLP regulation.
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004-04-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Limited information on the test item, test system and methodology.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The ocular irritancy potential of the test material was assessed using the Rabbit Enucleated Eye test (REET). This method involved the application of the test material onto the cornea of the enucleated eye.
GLP compliance:
no
Remarks:
Study was conducted in a facility operating to GLP within the UK national GLP monitoring programme, but study has been not audited by the QA unit. No formal claim of GLP compliance is made for the study.
Specific details on test material used for the study:
no data
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: New Zealand White strain of rabbit
- The eyes were maintained at a temperature of 32°C +/- 1.5°C within the superfusion apparatus.
Vehicle:
not specified
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (approximately 63 mg)
- Concentration (if solution): no data

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 0.9%
Duration of treatment / exposure:
single application
Observation period (in vivo):
240 minutes
Number of animals or in vitro replicates:
Three enucleated eyes were treated with the test item, two enucleated eyes were treated as control.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- washing: no

OBSERVATION TIME POINTS
- corneal opacity and corneal epithelium condition: 60, 120, 180 and 240 min
- fluorescein uptake: 240 min
- corneal swelling: 60, 120 and 240 min

SCORING SYSTEM: no data

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
cornea opacity score
Remarks:
mean of 3 eyes
Run / experiment:
1
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
other: fluorescein uptake
Run / experiment:
1
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
mean of 3 eyes 60 min post dosing
Run / experiment:
1
Value:
6.1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
mean of 3 eyes 120 post dosing
Run / experiment:
1
Value:
8.4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
mean of 3 eyes 240 min post dosing
Run / experiment:
1
Value:
8.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Other effects / acceptance of results:
Negative control:
- Corneal opacity: 0 (mean of 2 eyes)
- Corneal Epithelium Condition: normal (2 eyes)
- Fluorescein uptake: 0 (mean of 2 eyes)
- Corneal swelling (%): 8.3 at 60 min post dosing, 8.5 at 120 min post dosing, 9.4 at 240 min post dosing

Corneal epthelium condition was normal for all three test item treated eyes at all timepoints.
Interpretation of results:
GHS criteria not met
Conclusions:
Following assessment of the data for all endpoints, the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Ott (2006) investigated acute dermal irritation of T002907 in 1 male and 2 female New Zealand White rabbits after 4 hours of exposure to 0.5 g/animal of test item. Skin reactions were recorded 1, 24, 48, and 72 hours after exposure. Under the conditions of this study, no evidence of skin irritation was noted. Based on the results of this study, the test item does not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP regulation (EC) No 1272/2008.

In addition, in a K2 non-GLP study, Sanders (2004) investigated acute dermal irritation of T002907 in 3 male New Zealand White rabbits after 4 hours of exposure to 0.5 g/animal of test item. Skin reactions were recorded 1, 24, 48, and 72 hours after exposure. Very slight erythema was noted at all treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 24-hour observation. Based on the results of this study, the test item does not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP regulation (EC) No 1272/2008.

The GLP in vivo skin irritation study of 2006 is considered the key result for assessing the skin irritation endpoint, since the in vivo skin irritation study performed in 2004 was non-GLP compliant and limited information is available. As the result of the non-GLP in vivo skin irritation study of 2004 was negative, this study was added to the dossier as supporting evidence and the GLP compliant in vivo skin irritation study of 2006 is selected as key study for classification purposes.

 

An in vitro skin irritation study was waived based on the justification that adequate data from an in vivo skin irritation study are available.

Eye irritation:

Ott (2005) investigated eye irritation in an in vivo acute eye irritation/corrosion study in 1 male and 2 female New Zealand White rabbits. 0.1 g/animal of T002907 was applied to the eye. Eye irritation (cornea score, iris score, conjunctivae score and chemosis score) was scored according to Draize. Readings were performed at 1, 24, 47 and 72 hours after instillation. The conjunctivae score for animal #56 was 0.33 at the 1 and 24-hour time point. In addition, the chemosis score for animal #56 was 0.33 at the 24-hour time point. No abnormal findings were observed in the treated eye of any animal 48 hours after treatment. Based on the results of the study, the test item is considered to be not irritating to the rabbit eye. Based on the criteria of the CLP regulation (EC) 1272/2008, the test item should not be classified for eye irritation or serious eye damage. 

In addition, a rabbit enucleated eye test (REET) was performed by Sanders (2004) to assess the ocular irritancy potential of T002907. Three enucleated eyes, obtained from the New Zealand White strain of rabbit, were treated with 0.1 mL of test item (which weighed approximately 63 mg) of T002907. Corneal opacity (60, 120, 180 and 240 minutes after application), corneal swelling (60, 120 and 240 minutes after application) and fluorescein uptake (240 minutes after application) were observed and scored. Mean corneal opacity score and mean fluorescein uptake score were 0. Corneal swelling was 6.1%, 8.4% and 8.5% for the 60 min, 120 min and 240 min after application. The corneal epithelium condition was normal for all three test item treated eyes at all timepoints. Following assessment of the data for all endpoints, the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

 

The in vivo acute eye irritation/corrosion study is considered the key result for assessing the eye irritation endpoint. According to Chapter R.7a: Endpoint specific guidance Version 6.0 - July 2017 (R.7.2.11.2), data obtained from non-validated suitable in vitro tests can only be used according to the criteria set out in section 1.4 of Annex XI to the REACH Regulation, i.e. only positive results can be accepted in a weight of evidence approach. As the result of the non-validated REET test was negative, this study was added to the dossier as supporting evidence and the validated in vivo acute eye irritation/corrosion study was selected as key study for classification purposes.

 

An in vitro eye irritation study was waived based on the justification that adequate data from an in vivo eye irritation study are available.

 

Justification for classification or non-classification

Skin irritation:

According to the in vivo acute dermal irritation study, no dermal irritation was noted for T002907. The test item did not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP regulation (EC) No 1272/2008.

 

Eye irritation:

According to the in vivo acute eye irritation/corrosion study, T002907 is considered not irritating to the rabbit eye. No classification is required for eye irritation or serious eye damage according to the criteria of the CLP regulation (EC) No 1272/2008.