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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Irritation:
- skin: corrosive
- eye: corrosive

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
BASF-Test, see details in remarks on results.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.46 and 2.88 kg
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
1 min, 5 min, 15 min or 20 h.
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50% Lutrol
- Time after start of exposure: 1 min, 5 min and 15 min
Irritation parameter:
erythema score
Remarks:
, 1 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Remarks:
, 5 min
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: scale formation
Irritation parameter:
erythema score
Remarks:
, 15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: necrosis
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full thickness necrosis
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms

Mean erythema score after 24, 48 and 72 h (animal1/2)

 Exposure time 24 h 48 h 72 h mean
 1 min 1/1 0/0 0/0 0.3/0.3
5 min 1/1 0/1 0/1 0.3/1
15 min 1/3 0/3 0/2 0.3/2.7
 20 h 2/3 2/3 3/3 2/3 

Mean edema score after 24, 48 and 72 h (animal1/2)

 Exposure time 24 h 48 h 72 h mean
 1 min 0/0 0/0 0/0 0/0
 5 min 0/0 0/0 0/0 0/0
 15 min 0/0 0/0 0/0 0/0
 20 h 0/0 0/0 0/0 0/0

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period. The appearing necrosis is considered as a full thickness necrosis.

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Corrosive
Executive summary:

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 h post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
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
Principles of method if other than guideline:
BASF-Test, see details in remarks on results.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.87 and 2.92 kg
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
8 days (single application)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h -72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Findings animal1/2:

 Time   Opacity  Iritis    Erythema   Chemosis              
1h 1/3 0/0 2/2 2/2              
24h 1/3 0/0  2/2 2/2              
48h 1/1 1/2  2/2 1/1              
72h 3/3 1/2  2/2 1/2              
 8d 3/3 0/2 0/2  0/2              

Mean values over 24h, 48h and 72h:

Animal1: Opacity: 1.7; Iritis: 0.7; Erythema: 2; Chemosis: 1.3;

Animal2: Opacity: 2.3; Iritis: 1.3; Erythema: 2; Chemosis: 1.7;

The application of the test substance caused moderate to severe corneal opacity, irritis, moderate erythema and slight to moderate chemosis.

At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted. Severe corneal opacity, is considered to be an irreversible effect to ophthalmic tissue.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Irreversible effects on the eyes / serious damage to eyes
Executive summary:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period (BASF AG 1969). In two further skin irritation studies which are available as secondary sources, after a 1-3 min exposure no signs of irritation were observed. Slight to severe erythema were observed after a 60 min and 4 hour exposure period. Moderate oedema was also observed after 4 hours. (Huntsman et al. 1984). In a 4 h and 24 h exposure study severe erythema, oedema and necrosis, sloughing, fissuring were observed at the application sites (Huntsman et al. 1992).

 

Eye irritation:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted (BASF AG 1969). A further publication confirmed these severe corrosive effects (Smyth et al. 1951).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Endpoint conclusion: Adverse effect observed

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 1272/2008. The substance shows a skin and eye irritation potential and needs to be classified as corrosiv under Regulation (EC) No 1272/2008.