Registration Dossier

Administrative data

Description of key information

BASF (1961) found no skin irritation using rabbits, when given the unchanged test substance under occlusive conditions for 20 hours.

BASF (1961) reported no eye irritation effects after 1 and 24 hours after applying the substance into the eyes of rabbits.

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:
other: Early study report, short study description.
Principles of method if other than guideline:
according to BASF-internal standards
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Duration of treatment / exposure:
20 hour(s)
Observation period:
8 days
Number of animals:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
0
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: maximum score not specified
Interpretation of results:
GHS criteria not met
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study report, short study description.
Principles of method if other than guideline:
according to BASF-internal standards
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.05 mL (undiluted)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
Reading at 1 h, 24 h and 8 days after application.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no max. score specified
Irritant / corrosive response data:
No eye irritation effects were seen after 1 hour and 24 hours.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

BASF (1961) found no skin irritation using rabbits, when given the unchanged test substance under occlusive conditions for 20 hours. Classification concerning skin irritation is not warranted.

Guillot et al. (1982) reported a negative result concerning skin irritation. Rabbits were given the unchanged test substance under occlusive conditions for 23 hours (patch test).

EG can produce some skin irritation, but the other EGs tested on humans (DEG, TEG, and tetraEG) produce minimal irritation, and the human skin primary irritation index decreases with an increasing number of EG units (OECD SIDS 2004).

Eye irritation:

BASF (1961) reported no eye irritation effects after 1 and 24 hours. The undiluted test substance was given into the eyes of rabbits for 24 hours.

McDonald et al. (1972) showed a negative results regarding eye irritation. Rabbits were given ethylene glycol (0.05 ml in physiol. saline) in 10-min intervals for a 6-hour period. Irritation consisting of chemosis, swelling and conjunctival redness was observed in eyes treated with 4 and 40% concentrations. All eyes were normal by 7 days.

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. As a result the substance is not considered to be classified as skin or eye irritating /corrosive under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.