Registration Dossier

Administrative data

Description of key information

Triethanolamine is not irritating to the skin, eyes and respiratory tract. 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Mean weight at study initiation: males: 2.34 kg; females 2.41 kg
- Housing: individual
- Diet: 130 g/day (Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, Germany)
- Water: 250 ml tap water/day
- Acclimatisation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hrs
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol, water (1:1)
- Time after start of exposure: 4 hrs

SCORING SYSTEM: according to Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

4 h

1

0

0

 

2

0

0

 

3

0

0

 

24 h

1

0

0

 

2

0

0

 

3

0

0

 

48 h

1

0

0

 

2

0

0

 

3

0

0

 

72 h

1

0

0

 

2

0

0

 

3

0

0

 

Mean

24, 48, 72 h

1

0

0

 

2

0

0

 

3

0

0

 

Mean 24, 48, 72 h

1-3

0

0

 

(Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983)

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No. XXI/170


Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Mean Weight at study initiation: 2.45 kg
- Diet: Altromin MS (Altroge, Germany) ad libitum
- Water: ad libitum


Vehicle:
unchanged (no vehicle)
Controls:
other: concurrent saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 m³
- Concentration: concentrated
Duration of treatment / exposure:
not applicable (substance was not washed out)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 (m/f)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

Readings at 10 min, 1 and 24 hrs, 3 and 8 days

SCORING SYSTEM: initial scoring system was converted into Draize-scores
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24 hours
Score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8 days
Score:
0
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours, 8 days
Score:
0
Reversibility:
fully reversible within: 8 days

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

-

-

-

1

1

-

 

2

-

-

-

1

1

-

 

24 h

1

-

-

-

1

0

-

 

2

-

-

-

1

0

-

 

48 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

72 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

8 d

1

-

-

-

0

0

-

 

2

-

-

-

0

0

-

 

Mean

24 -72 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

Mean

24-72 h

1-2

 

 

 

 

 

 

 

Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Draize Test according to Draize JH, Woodard G and Galvery HO. J. Pharmacol. Exp. Ther. 82:377, 1944. and CEPA (Corneal Epithelial Plasminogen Activator) Test
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Analytical purity: 98 %
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.03, and 0.1 mL
- Concentration (if solution): unchanged
Duration of treatment / exposure:
not applicable (eyes were not washed out)
Observation period (in vivo):
21 day
Number of animals or in vitro replicates:
6 per dose
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 3, 7, 14, 21 days
Score:
0
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: 0.01 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 day
Score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: 0.03 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 day
Score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 0.1 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 3, 7 days
Score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 0.1 mL

Rabit eye irritation scores and days to clear with different dose volumes

Maximum Draize score (mean ±SE) Dose (mL)

Number of days to return to normal Dose (mL)

0.01

0.03

0.1

0.01

0.03

0.1

0 ± 0

1 ± 1

4 ± 1

1

1

3

 

Rabbit eye irritation scores at various times after instillation of TEA (Draize score (mean +/- SE)

Test material

Dose volume

Number of animals tested

Day

Maximum

Median day to clear

1

3

7

14

21

TEA

0.01

6

0 ± 0

0 ± 0

0 ± 0

0 ± 0

0 ± 0

0 ± 0

1

0.03

6

1 ± 1

0 ± 0

0 ± 0

0 ± 0

0 ± 0

1 ± 1

1

0.10

6

4 ± 1

2 ± 2

2 ± 2

0 ± 0

0 ± 0

6 ± 1

3

* Each value is the average ± SE for 6 animals.

 

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

In a skin irritation test performed according to OECD guideline 404 (not GLP-compliant), three rabbits were exposed to TEA using an occlusive application for 4 hours. Erythema and edema were scored at 4, 24, 48, and 72 hours and the mean score was 0 in all animals. The test substance was not a skin irritant under the conditions of this study (BASF, 1983).Several other studies, in which rabbits were exposed for up to 20 hours, yielded similar results (BASF 1956, 1966, 1967, 1971).

In a study with 6 human volunteers, 2 cm2-patches soaked with the test material were applied for 24 hours to the upper arm, and skin irritation was scored upon patch removal and 24 hours thereafter (BASF AG, 1930). Besides slight biting and reddening in 1 subject, no irritation was observed and thus, the test substance was judged non-irritating.

 

In an eye irritation test equivalent to OECD guideline 405 (non GLP-compliant), 6 rabbits/dose were exposed to undiluted TEA at dose volumes of 0.01, 0.03, and 0.1 mL. The eyes were not irrigated. Eyes were examined and scored according to Draize et al. (1944) 1, 3, 7, 14, and 21 days after dosing. TEA was not an eye irritant under the conditions of this study (Griffith, 1980). The same conclusion was reached in an eye irritation test (non GLP-compliant, according to internal BASF standards), in which 50 µL of the test substance was instilled into the eyes of 2 rabbits, and irritation was scored 10 min, 1 and 24 hours and 8 days after administration (BASF AG, 1971). In addition, no eye irritation was observed in response to the application of 0.5 mL 20% TEA in water at pH 10 and pH 8 (BASF AG, 1956). Two other studies (performed according to internal BASF standards) demonstrated some mild irritation due to the application of 50 µL undiluted TEA to the rabbit eye, which was not fully reversible within 8 days in one animal (BASF AG, 1966, 1967). Overall, TEA is judged not to be irritating to the eyes.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation, the test item is not classified as skin or eye irritant according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.