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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral:

Data on THEICTA as mono-constituent substance indicates an LD in rats above 2000 mg/kg. Data on TMPTA indicates low acute toxicity potential as LD50 (rats) >5000 mg/kg bw. Thus, based on these data and due to close structural similarity to Reaction mass of THEICTA and THEICDA the oral LD50 can be estimated to be above 2000 mg/kg bw for Reaction mass of THEICTA and THEICDA as well.

Inhalation:

No toxicity was observed in a study where rats were exposed to saturated vapours (0.5 mg/L) of TMPTA for 6 hours. Thus an LC50 > 0.5 mg/L can be estimated for Reaction mass of THEICTA and THEICDA as well.

Dermal:

Data on TMPTA indicates low acute toxicity potential as LD50 (rats) > 5170 mg/kg bw. Thus, due to close structural similarity to Reaction mass of THEICTA and THEICDA the dermal LD50 can be estimated to > 2000 mg/kg bw for Reaction mass of THEICTA and THEICDA as well.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September / October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 206-240 g (females), 205-220 g (males)
- Weight at study initiation: 8 weeks
- Fasting period before study: yes
- Housing: by group of 3, by sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
The test mateiral was fresly prepared as a solution at the appropriate concentration in arachis oil BP. If necessary the test material was warmed to approximately 50°C to produce a liquid prior to formulation.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bw at the time of dosing.
Dose volume : 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females and 4 males
Control animals:
no
Details on study design:
The animals were observed for deaths or overt signs of toxicity, 30 min, 1h, 2h and 4h after dosing and subsequently once daily for up to 14 days.
individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death.
At the end of the observation period the surviving animals were killed by cervical dislocation. All animal including the one that was killed in extremis were subjected to gross pathological examination. This consisted of an external examination and opening of the abdonimal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
no
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No treatment related deaths were noted.
One male animal was killed in extremis approximately 3 hours after dosing. necropsy confirmed the animal had been mal-dosed and an additional animal was treated.
Clinical signs:
Signs of systemic toxicity noted in males were hunched posture, decreased respiration and noisy respiration. Two males recovered four or five days after dosing. One male and all females appeared normal throughout the study.
The animal killed in extremis due to the mal-doseing showed signs of hunched posture, lethargy, noisy respiration and gasping respiration one and two hours after dosing.
Body weight:
Expected gains in bodyweight were noted over the study period.
Gross pathology:
Off white liquid present in the lungs (considered to be the test material) was noted at necropsy of the male that was killed in extremis during the day of dosing and confirmed mal-dosing.
No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Other findings:
no
Interpretation of results:
GHS criteria not met
Conclusions:
The oral acute median lethal dose (LD50) of the test mateiral in the SD rat was estimated greater than 2000 mg/kg bw.
Executive summary:

The study was performed to assess the acute oral toxicity of the tes material following a single oral administration in the SD strain rat (OECD 423).

A group of 3 fasted females was treated with 2000 mg/kg bw. This was followed by a group of 3 fasted males at the same dose level. An additional male animal was treated with 2000 mg/kg to replace a mal-dosed male animal. The test material was administered orally as a solution in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination.

No treatment related deaths were noted. One male animal was killed in extremis approximately three hours after dosing. Necropsy confirmed the animal had been mal-dosed and an additional animal was treated. Signs of systemic toxicity noted in males were hunched posture, decreased respiration and noisy respiration. Two males receovered four or five days after dosing. One male and all females appeared normal throughout the study. Expected gains in bodyweight were noted over the study period. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

The oral acute median lethal dose (LD50) of the test mateiral in the SD rat was estimated greater than 2000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Source: NISSAN CHEMICAL INDUSTRIES, LTD.
- Lot No. 00915-1
- Purity: 99.0 %
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at study initiation: 5 weeks old
Route of administration:
oral: gavage
Vehicle:
water
Doses:
Doses:0, 500, 1,000, 2,000 mg/kg bw
No. of animals per sex per dose:
- No. of animals: 5 animals/sex/group
Details on study design:
- Clinical observation: Just before administration, 30 minutes, 2, 4, 6 h after
administration on the day of treatment, once a day for the other days.
- Observation period: 14 days
- Body weight change: Day of treatment and at 1, 3, 7, 10, 14 days after
treatment.
- Necropsy
Statistics:
not specified
Preliminary study:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
No treatment related clinical sign, no death observed.
Body weight:
Significant difference was not observed in body weight gain.
Gross pathology:
No treatment related effect was observed at necropsy.
Other findings:
NA
Interpretation of results:
GHS criteria not met
Executive summary:

The toxicity of 1,3,5-TRIAZINE-2,4,6(1H,3H,5H)-TRIONE,1,3,5-TRIS(2HYDROXYETHYL) (S3) was assesed in a OECD TG 401 Acute oral toxicity study performed under GLP. Five animals/sex/group treated with a single dose of 0, 500, 1,000, 2,000 mg/kg bw. No death occurred in the study, thus LD50 was found to be above 2000 mg/kg bw.

Endpoint:
acute toxicity: oral
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), TMPTA (S2) and Tris(2-hydroxyethyl)isocyanurate (S3).
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: data on read-across substance
Interpretation of results:
GHS criteria not met
Executive summary:

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

Data on THEICTA as mono-constituent substance indicates an LD0in rats above 2000 mg/kg. Data on TMPTA indicates low acute toxicity potential as LD50 (rats) >5000 mg/kg bw.

Also, LD0 of Tris(2-hydroxyethyl) isocyanurate (S3) that may be generated by complete hydrolysis is above 2000 mg/kg bw.

Thus, based on these data and due to close structural similarity to Reaction mass of THEICTA and THEICDA the oral LD50 can be estimated to be above 2000 mg/kg bw for Reaction mass of THEICTA and THEICDA as well.

See justification for read-across attached in section 13.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Principles of method if other than guideline:
An acute oral toxicity study was performed in Sprague-Dawley rats. Test material was administered at 6 graduated doses and observations were made for a period of 14 d.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Flow Laboratories
- Fasting period before study: Yes, overnight


Route of administration:
oral: gavage
Vehicle:
other: 5 % Acacia for 50, 127.5 & 315.1 mg/kg bw doses
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 % suspensions stabilized in 5 % Acacia (for 50, 127.5 & 315.1 mg/kg bw doses); other doses were given undiluted.

Doses:
50.0, 127.5, 315.1, 785, 1999, 5000 mg/kg bw
No. of animals per sex per dose:
5 rats/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed frequently during the first 4 h, and at least daily thereafter for 14 d
Statistics:
Not applicable
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: None
Mortality:
No mortalities were observed, except 2 animals died at dose level of 5000 mg/kg bw
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Table1.Summary of mortality data

Dose Level

mg/kg bw

Number Dead/

Number Tested

50.0

0/5

127.5

0/5

315.1

0/5

795.0

0/5

1999

0/5

5000

2/5
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test substance (trimethylolpropane triacrylate - TMPTA) in rats was calculated to be > 5000 mg/kg bw. Therefore, no classification is required according to EU criteria.
Executive summary:

A study was conducted to assess the single dose toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in Sprague-Dawley rats using the standard acute method.

Groups of 5 Sprague-Dawley rats/dose (sex unspecified) received a single oral (gavage) dose of 50.0, 127.5, 315.1, 785, 1999, 5000 mg/kg. The test substance (trimethylolpropane triacrylate - TMPTA). The three lower doses were administered as 10% suspensions stabilized by the incorporation of 5% acacia, while the three higher doses were administered undiluted. Parameters evaluated included survival and clinical observations on the day of dosing and at least daily thereafter for 14 d.

No mortalities were observed except in two of the five animals in the 5000 mg/kg bw group.

In conclusion, the single oral median lethal dose (LD50) of the test substance (trimethylolpropane triacrylate - TMPTA) in rats was calculated to be >5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Four studies available, with a klimisch score of 1 - 2. Low toxicity LD50>2000 mg/kg (TMPTA)

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD TG 403
Version / remarks:
Smyth-Carpenter, Am. Ind. Hyg . Anal. (1962) 27, 95 on which OECD TG 403,
Annex 5 was based
Deviations:
yes
Remarks:
8 h, rather than 7h exposure
GLP compliance:
no
Specific details on test material used for the study:
-Test substance : Purity: 99%
-Source : BASF AG Ludwigshafen
-Reliability : (2) Valid with restriction
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
-Sprague-Dawley Rats, male and female.
-Number of animals : 3 animals/sex/group.
Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
Test condition : - Volume administered or concentration: 200 L air/h; 9.32 and 15 mg/L nominal dust concentrations.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Remarks on duration:
8 h, rather than 7h according to OECD TG 403.
Concentrations:
200 L air/h; 9.32 and 15 mg/L nominal dust concentrations.
No. of animals per sex per dose:
3 animals/sex/group
Control animals:
yes
Remarks:
air control grou
Details on study design:
-Volume administered or concentration: 200 L air/h; 9.32 and 15 mg/L
nominal dust concentrations.
- Clinical observation: 5 times at day of treatment, afterwards daily besides
weekends until necropsy.
- Observation period: 7 days
- Body weight change: Day of treatment and at 7 days after treatment.
- Necropsy
Statistics:
not specified
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 15 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Mortality:
No mortality and no symptoms were observed.
Clinical signs:
other: No symptoms were observed.
Body weight:
No effect was observed in body weight change
Gross pathology:
No effect was observed at necropsy.
Other findings:
No toxicity found.
Executive summary:

The toxicity of 1,3,5-TRIAZINE-2,4,6(1H,3H,5H)-TRIONE,1,3,5-TRIS(2HYDROXYETHYL) (S3) was assesed in a OECD TG 403 : Dust inhalation hazard study performed under GLP. Three animals/sex/group were exposed to 200 L air/h; 9.32 and 15 mg/L nominal dust concentrations for 8 hours. No mortallity or inhalation hazards were observed from volatile parts/dust formation under these test conditions.

Endpoint:
acute toxicity: inhalation
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 TMPTA (S2) and Tris(2-hydroxyethyl) isocyanurate (S3) .
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
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.55 mg/L air
Based on:
test mat.
Exp. duration:
6 h
Interpretation of results:
GHS criteria not met
Executive summary:

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

From acute inhalational toxicity testing of S2 no mortality was observed for male/female rats at the highest tested dose 0.55 mg/L for 6 hours, thus LC>0.55 mg/L. Due to structural and pysico-chemical similarity to Reaction mass of THEICTA and THEICDA, LC50>0.55 mg/L can also be concluded for Reaction mass of THEICTA and THEICDA as well.

S(3) that may be generated from full hydrolysis of (T) has an LC value above 15mg/L.

See justification for read-across attached in section 13.

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
In an acute inhalation study, rats were exposed to the vapor of the test material at a single concentration for 6 h followed by observation for 14 d.
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
no
Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Rate of air: 3.26 L/min.
- System of generating vapor: The vapor was generated by bubbling a stream of clean, dry air (-40 °C dewpoint) through the undiluted test material in a gas washing bottle.
- Temperature in air chamber: 24 °C
- Pressure in air chamber: 29.91 inches Hg

Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 6 h
Concentrations:
0.55 mg/L air (nominal)
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight
Statistics:
No data
Preliminary study:
No data
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.55 mg/L air (nominal)
Exp. duration:
6 h
Mortality:
No mortality
Clinical signs:
other: No untoward reactions
Body weight:
Body weight gains were within the normal limits
Gross pathology:
No gross pathologic alterations
Other findings:
None

None

Conclusions:
Under the test conditions, the inhalation LC50 of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be greater than 0.55 mg/L after 6 h exposure in rats.
Executive summary:

A study was conducted to evaluate the acute inhalation toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in rats.

5 Charles River rats/sex were exposed to the vapor of the test substance (trimethylolpropane triacrylate - TMPTA) at a single concentration of 0.55 mg/L air (nominal) for 6 h followed by and observation period of 14 days. Body weight was measured during the observation period and necropsy was performed at the end of this period.

There were no untoward reactions noted during exposure or during the 14 day observation period. The average body weight gains were within the normal limits. Necropsy, performed on all rats at the end of the observation period, did not reveal any gross pathologic alterations.

 

In conclusion, the LC0 and median lethal inhalation (LC50) of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be greater than 0.55 mg/L after 6 h exposure in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
0.001 mg/m³
Quality of whole database:
One key study available (weight of evidence) with a klimisch score of 2. No toxicity observed i.e. LC50 > 0.55 mg/m3 = 0.00055 mg/m³ (TMPTA)

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
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 TMPTA (S2).
See further read-acoss justification in attached document to section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: read-across test material
Interpretation of results:
GHS criteria not met
Executive summary:

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

From acute dermal toxicity testing of S2 in rats the LD50 value was found to be above 5170 mg/kg bw, the highest dose tested. Due to structural and pysico-chemical similarity to Reaction mass of THEICTA and THEICDA, a dermal LD50 > 2000 mg/kg bw can also be concluded for Reaction mass of THEICTA and THEICDA as well.

See justification for read-across attached in section 13.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Principles of method if other than guideline:
An acute dermal toxicity study was performed in albino rabbits. The test material was applied topically via a 24 h occlusive patch and observations were made for a period of seven days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Rubber dam, held in place by tape.
- Other: Animals were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded.


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
0.315, 0.795, 1. 99 and 5.0 mL/kg bw
No. of animals per sex per dose:
4 per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 d
- Necropsy of survivors performed: Yes
Statistics:
No data
Preliminary study:
No
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4.7 mL/kg bw
Remarks on result:
other: equivalent to 5170 mg/kg bw assuming density of test material as 1.1 g/mL
Mortality:
One each in 1.99 and 5.0 mL/kg bw dose groups
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
- Other observations (skin irritation): In some cases, the test material caused no erythema or edema, but in others caused severe effects.

Table 1: Number of observed mortalities:

Dosage (mL/kg bw) Mortality
0.315 0/4
0.795 0/4
1. 99 1/4
5 1/4
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be above 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits. Therefore no classification is required according to the EU CLP criteria.
Executive summary:

A study was conducted to evaluate the acute dermal toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in rabbits.

Sixteen albino rabbits were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded. After weighing the animal, the calculated dose was applied and the entire area covered with a rubber dam, held in place by tape. The dose levels applied were 0.315, 0.795, 1.99 and 5.0 mL/kg bw the test substance (trimethylolpropane triacrylate - TMPTA).

Four animals were included in each dose group. 24 h later, the binders were removed and an effort made to remove any remaining material from the skin surface. A score of the local effects, according to the method of Draize, was recorded. The animals were observed repeatedly for seven days at the end of which time they were killed and necropsy was performed.

One mortality was observed at dose levels 1.99 and 5.0 mL/kg bw. In some cases, the test substance (trimethylolpropane triacrylate - TMPTA)

caused no erythema or edema, but in others caused severe effects.

In conclusion, the single dermal median lethal dose (LD50) of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be above 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
One study available,with a klimisch score of 2. Low toxicity, LD50 >5170 mg/kg bw for TMPTA; i.e. LD50 > 2000 mg/kg bw

Additional information

Acute toxicity, oral: 

Data on THEICTA as mono-constituent substance indicates an LD in rats above 2000 mg/kg. Data on TMPTA indicates low acute toxicity potential as LD50 (rats) > 2000 mg/kg bw. Thus, based on these data and due to close structural similarity to Reaction mass of THEICTA and THEICDA the oral LD50 can be estimated to be above 2000 mg/kg bw for Reaction mass of THEICTA and THEICDA as well.

Acute toxicity, dermal: 

Data on TMPTA indicates low acute toxicity potential as LD50 (rats) > 5170 mg/kg bw. Thus, due to close structural similarity to Reaction mass of THEICTA and THEICDA the dermal LD50 can be estimated to > 2000 mg/kg bw for Reaction mass of THEICTA and THEICDA as well.

Acute toxicity, inhalation:No toxicity was observed in a study where rats were exposed to saturated vapours (0.5 mg/L) of TMPTA for 6 hours. Thus an LC50 > 0.5 mg/L can be estimated for Reaction mass of THEICTA and THEICDA as well.

 

Justification for selection of acute toxicity – oral endpoint

Three acute oral toxicity studies available, S1, S2 and S3. As the three available studies indicate a LD50 above 2000 mg/kg bw no oral toxicity hazard is expected.

Justification for selection of acute toxicity – inhalation endpoint

One study available on S2. The study was found to be satisfying to meet general scientific accepted principles, but with less detailed documentation and did not follow a guideline. The LC50 is concluded to be greater than 0.55 mg/L after 6hours exposure in rats

 

Justification for selection of acute toxicity – dermal endpoint

One acute dermal toxicity study in rabbit. The study indicated a LD50 above 5000 mg/kg bw and no dermal toxicity hazard is expected. The study was well conducted and met general accepted scientific principles.

Justification for classification or non-classification

As the oral and dermal LD50 values are estimated to be above 2000 mg/kg bw no CLP classification for acute toxicity should apply for these exposure routes for Reaction mass ofTHEICTA and THEICDA.

An acute inhalation toxicity test reveals no deaths in the highest administered concentration (LC0=0.55mg/L) of the read-across substance TMPTA. This concentration reflects the maximum vapour concentration (saturation concentration). Thus, information is lacking for the acute toxic potential at higher exposure levels.

Due to lack of data Reaction mass of THEICTA and THEIDA is not to be classified for acute toxicity by inhalation.