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Diss Factsheets

Administrative data

Description of key information

One in vivo test for the testing of skin corrosion and skin irritation was available. The test showed no skin irritant or corrosive effects. Therefore, the test substance was considered for no classification for skin corrosion/irritation.

One in vitro test for eye irritation according to OECD TG 492 was performed and showed no irritant effects.The test substance is classified as non-irritant in accordance with UN GHS No Category.

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:
Nov. - Dec. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Analog hazardous substances, Part. 191, Section 11, FDA, Washington 1965
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Weight at study initiation: males/females 2.3 - 2.8 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 60 +/-3
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
open
Preparation of test site:
other: shaved and scarified
Vehicle:
unchanged (no vehicle)
Controls:
other: 1% methyhydroxyethylcellulose Gel MH 300 P
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 2.0 ml/kg
Concentrations of test material: 1. 30% solution, 2. 15% solution
Duration of treatment / exposure:
24 hours
Observation period:
0, 24 h, 48 h, 72 h, 14 days daily
Number of animals:
36 in total, 3 per sex and group
Details on study design:
TEST SITE
- Area of exposure: 20 x 20 cm
Application of test substance: 1. intact skin 2. scarified skin

OBSERVATION
- clinical signs, water and food consumption, body weight were checked daily

Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, TMT solution 30%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, TMT solution 30%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, TMT solution 10%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, TMT solution 10%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, control animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, control animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant response or serious lesion was noted during the 72-hour and 14 days observation period, no edema were present
Other effects:
No signs of incompatibility and no clinical effects, changes in water/food consumption or body weight gain were evident
Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no corrosive or irritant effects. Based on these information, the test item does not require classification and labeling according to CLP Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08.10.2019 to 18.11.2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
human
Details on test animals or tissues and environmental conditions:
This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The MatTek EpiOcular™ model has been widely used as a research and testing model for many years.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 mg of test item
Duration of treatment / exposure:
6 h
Duration of post- treatment incubation (in vitro):
18 h
Number of animals or in vitro replicates:
2
Irritation parameter:
other: mean relative tissue viability [%]
Run / experiment:
1
Value:
72.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no irritant effects. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (72.8%). The test item is classified as “non-irritant“ in accordance with UN GHS “No Category”.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion:

Taicros TMT was tested for acute dermal irritation/corrosion as 30% and 10% solution in a study comparable to guideline. No corrosive or irritant effects were evident for intact and abraded skin after direct exposure or during 14 days observation period.

No skin irritation was observed after a single dermal dose of 10.0 g/kg to 5 albino rabbits.

Eye irritation:

The eye irritating potential of TAICROS TMT was analysed according to OECD TG 492. In this study under the given conditions the test item showed no irritant effects.

Justification for classification or non-classification

Based on the available information and in the absence of irritating effects, the test substance Taicros TMT does not need to be classified for Skin Irrit./Corr. or Eye Irrit./Dam. according to CLP Regulation (EC) 1271/2008.