Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation:

In vivo data on THEICTA as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA is subject to an EU harmonised classification as Skin Irrit. 2. 

Eye irritation:In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. Data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Data on target substance not available. Thus, read-across has been applied using data from the source substance THEICTA (S1) and TMPTA (S2).
See further read-acoss justification in attached document to section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7d
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Executive summary:

No data is available for Reaction mass of THEICTA and THEICDA (T).

In vivo data on THEICTA (S1) as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA (S2) is subject to an EU-harmonised classification as Skin Irrit 2. Based on these data Reaction mass of THEICTA and THEICDA may be considered as borderline for skin irritation. Using the data in a precautious way Reaction mass of THEICTA and THEICDA is to be classified as Skin Irrit. 2

See justification for read-across attached in section 13.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13-19 weeks if age
- Weight at study initiation: 2.9-3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of the test substance was applied under a 25 mm x 25 mm gauze pad moistened with 0.5 ml distilled water to one intact skin site of each animal
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
The test substance was administered following grinding using a pestle and mortar.
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water ( 30°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
All animals were observed daily for signs of ill health or toxicity.
Dermal examination of the treated skin was made on Day 1 (60 minutes after removal of the dressings) and on Days 2, 3, and 4 (equivalent to 24, 48 and 72 hours after exposure).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal irritation was observed at 60 min, 24h, 48h and 72h after patch removal.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occlusive application of the test substance to intact rabbit skin for 4h elicited no dermal irritation.
Executive summary:

A study was performed to assess the skin irritation potential of the test item to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed following a single semi-occlusive dermal application of the test substance to intact rabbit skin for four hours. Based on these results, the test substance is considered as not skin irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 July 1996 to 22 July 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 404 with minor deviations: no certificate of analysis, no data on the purity of the test substance, observation period of 7 days instead of 14 days.
Qualifier:
according to guideline
Guideline:
other: OECD Guideline No. 404 adopted in July 1992
Deviations:
yes
Remarks:
: no certificate of analysis, no data on the purity of the test substance, observation period of reversibility for 7 days instead of 14 days.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Aace animals, Boyertown, PA, USA
- Age at study initiation: about 3 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: individually in wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321), provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 1996-03-31 to 1996-04-14
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 hours and on day 7 after the removal of the dressing.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm on the dorso area of the trunk
- Type of wrap if used: 25 mm x 25 mm gauze pad covered with a non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM:

Erythema & Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
ca. 1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
ca. 1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48, 72 h
Score:
ca. 1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Erythema scores ranged from very slight to well defined through 72 hours after patch removal, and from absent to very slight on day 7.
Edema scores ranged from absent to slight through 48 hours after patch removal, and from absent to very slight through day 7.
See details in Table 7.3.1/1
Other effects:
For one animal, 48 hours after the removal of the dressing, diarrhea and wetness of the anogenital area were observed. Seven days after the removal of the dressing all animals presented skin flaking.

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema and Eschar formation

Edema

Max. score: 4

Max. score: 4

1h

1/1/2

0/0/2

24 h

1/2/2

0/1/1

48 h

2/2/2

1/1/2

72 h

1/1/2

0/0/1

Average 24h, 48h, 72h

1.3/1.7/2

0.3/0.7/1.3

Reversibility (within 7 days)a

n.c.b

n.c.

Average time (unit) for reversion

?

?

aReversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

bFlaking skin

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, SR 351 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Executive summary:

In a dermal irritation GLP study performed according to the OECD guideline No. 404 (approved in July 1992), three young adult male White New-Zealand rabbits were dermally exposed to 0.5 mL of test article for 4 hours to 6.25 cm² of clipped skin in semi-occlusive conditions. Animals then were observed for 7 days. Reactions were scored again at 24, 48 and 72 hours and on day 7. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods.

Under the test conditions, there were slightly irritant effects, with mean individual scores within 24, 48 and 72 hrs of 1.3/1.7/2.0 for erythema and 0.3/0.7/1.3 for edema. These effects were not fully reversible within 7 days for one animal only. Considering these scores the test substance is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

Primary Irritation Index is 2.00

Although the classification criteria in this key study was not met the study has to be assessed with a series of other tests on skin irritation of TMPTA:

Clear skin irritating effects were observed in three skin irritation studies according to OECD guideline. The

scores obtained from the study led to no classification according to CLP EC 1272/2008 as the mean value are

below 2.3 for erythema/eschar or oedema in at least 2 of 3 animals and as the inflammation does not persist in 2

animals over a 14 day observation period.

Nevertheless, there is an EU harmonised (CLP annex VI) classification as Skin irrit 2 and thus this classification should be applied for TMPTA.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted and documented study
Qualifier:
equivalent or similar to guideline
Guideline:
other: In general the techniques of tests as published by the FDA af the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gosmet. Industr. 71 (1952) 36) are followed.
Principles of method if other than guideline:
Principles according to Draize
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Ihe animais are caged individually and receive no hay or other extranous material that might enter the eyes
Vehicle:
unchanged (no vehicle)
Controls:
other: second eye serves as control
Amount / concentration applied:
- undiluted
- 100µL
Duration of treatment / exposure:
Treatment: After installtion the upper and lower eye lid are then carefully clased and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, serves as a control.The eyes are not washed following instillation and the animals
are released immediately.
Observation period (in vivo):
The eyes are examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
2
Details on study design:
Ocular reactions are judged using the scoring seale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 48h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
other: 48h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
other: 72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 48h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 48h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 72h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 48h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 48h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 72h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
no corrosive effects reported
Interpretation of results:
other:
Conclusions:
From the present results it can be coneluded that the compound na. 77/767 is moderately irritating to the eye.
Executive summary:

A eye irritation study according to the general techniques as published by the FDA of the(Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gasmet. Industr. 71 (1952) 36) was conducted to assess the eye irritation potential of TMPTA.

Therefore two New Zealand White albino rabbits received 100 milligrams of the test substance. No washout followed the instillation and the eyes are examined at one hour, 24, 48, 72 hours and 7 days. Ocular reactions are judged using the scoring scale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)

During the first day after instillation the eyes showed slight corneal damage, slight iritis and moderate to severe lesions of the conjunctivae.

In the course of the seven-day observation period the degree of corneal

damage increased. After seven days the following ocular lesions were observed: moderate or moderate-severe corneal opacity, slight iritis and moderate conjunctivitis.

The author concluded that, according to the classification used, the test material is moderately irritating to the eye.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Data on target substance not available. Thus, read-across has been applied using data from the source substance THEICTA (S1) whcih is the mnain constituent in the target substance and TMPTA (S2).
See further read-acoss justification in attached document to section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with haemorrhage and necrosis
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with nictating membrane swollen
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In vivo study in rabbit, performed according to the EU.B.5. guideline THEICTA (S1) suggest that the targent substance Reaction mass of THEICTA and THEICDA should be classified as Eye damage 1.
Executive summary:

In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. In vivo data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2. Thus, due to the high content of THEICTA in Reaction mass of THEICTA and THEICDA a classification as Eye damage 1 should be apply for Reaction mass of THEICTA and THEICDA.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13 weeks if age
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were ten gently held together for one second before releasing. The contralateral eye remained untreated.
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1 hour and 1 day after exposure
Number of animals or in vitro replicates:
1 animal
Details on study design:
The eyes were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated initially, to ensure that if a severe response was produced, no further animals would be exposed. On this occasion, due to the severity of the reactions, no further animals were used.
The animal was observed daily for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour and on two occasions one day after instillation. Observation of the eyes was aided by the use of a handheld light.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with necrosis and haemorrhage
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with nictating membrane swollen
Irritant / corrosive response data:
Corneal opacities developed one day after instillation.
Iridial inflammation (grade 2) was observed.
A diffuse crimson or beefy red colouration of the conjunctivae accompanied by swelling with the eyelids more than half closed was seen. Necrosis and haemorrhage was seen on the nictating membrane and lower eyelid. A red/brown discharge was also seen before the animal was killed.
Due to the severity of the reactions, the animal was killed one day after instillation and no further animals were treated.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
Executive summary:

A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Eye irritation:

An eye irritation study with THEICTA (S1) as monoconstituent in rabbit performed according to the EU .B.5. guideline where one rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.

Justification for classification or non-classification

Skin irritation:

In vivo data on THEICTA as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA is subject to an EU harmonised classification as Skin Irrit. 2. 

Based on these data Reaction mass of THEICTA and THEICDA (T) may be considered as borderline for skin irritation.

Using the data in a precautious way Reaction mass of THEICTA and THEICDA is to be classified as Skin Irrit. 2

Eye irritation:

In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. Data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2. 

Thus, due to the high content of THEICTA in Reaction mass of THEICTA and THEICDA a classification as Eye damage 1 should be apply for Reaction mass of THEICTA and THEICDA.

Classification for Reaction mass of THEICTA and THIECDA:

Skin: GHS classification (Skin irrit 2, H315).

Eye: GHS classification (Eye damage 1, H318).