Registration Dossier

Administrative data

Description of key information

Skin irritation:  not irritating
Eye irritation: not irritating

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:
1991-10-08 to 1991-10-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation:2.8-2.9 kg
- Housing: single cages in air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): 12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%, undiluted

Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 28, 72 hours after treatment
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0.8
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification is warranted.
Executive summary:

Tetraglyme was tested for its skin irritant properties according to OECD Guideline 404. Very slight to well-defined erythema were seen on during the observation period. No edema was observed. All the effects were fully reversible.

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Ka stengrund, konventionell e Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4-3.9 kg
- Housing: single cages in air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): 12
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification is warranted.
Executive summary:

Tetraglyme was tested for its eye irritant properties equivalent to OECD Guideline 405. At 24 hours after application, clear colorless discharge and conjunctical hyperemia blood vessel were observed in one animal.The other two animals did not show any effects.

Under the conditions of this test, the test item was valued as "non irritant" according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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

Additional information

Tetraglyme was tested for its skin irritant properties according to OECD Guideline 404. Very slight to well-defined erythema were seen on during the observation period. No edema was observed. All the effects were fully reversible.

Tetraglyme was tested for its eye irritant properties equivalent to OECD Guideline 405. At 24 hours after application, clear colorless discharge and conjunctical hyperemia blood vessel were observed in one animal.The other two animals did not show any effects.


Justification for selection of skin irritation / corrosion endpoint:
Sicentifically well performed study

Justification for selection of eye irritation endpoint:
Scientifically well performed study

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).