2-[(2-ethylhexyl)oxy]ethanol

Endpoint summary

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

This work was done in the early days of GLP prior to guidelines in use. As such, study documentation is lacking, but the study was conducted at a superior facility, so the quality of the results are not in question

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Not provided

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

Not provided

Type of coverage:

occlusive

Preparation of test site:

other: Depiliated

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

20 ml/kg

Duration of treatment / exposure:

24 hours

Observation period:

Not provided

Number of animals:

Not provided

Details on study design:

Not provided

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Not provided

Eye and skin irritation was conducted in 1980/1981, at the start of GLP. As a result, the reports are generally under-reported, as standards for report content had not yet been set. The report exists as more of a short summary of the findings, while the primary details of the conduct were kept in generic standard operating proceedures that were applicable to each type of study. As such, individual numeric evaluations were not available for these tests, and the results are reported out in a more general qualatative description. The values for the results provided here are not real and are only placeholders as TCC demanded some sort of entry, even if one was not available.

The laboratory where this work was conducted was the state of the art at the time, and was one of the top labs in the world. We have no reason to doubt the results of the studies, but the findings are not reported out in such way that they are very applicable to entry as a robust summary today.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The authors provided a statement that it was moderately irritating to skin

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

The study was conducted at a GLP facility prior to guideline use. The work was done in the early days of GLP, and as such, documentation of data is lacking, but a superior facility was used, so data quality and conslusions are not in question.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

None provided

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

None provided

Vehicle:

unchanged (no vehicle)

Controls:

other: Treated eyes were either unwashed or washed immediately after application

Amount / concentration applied:

None provided

Duration of treatment / exposure:

None provided

Observation period (in vivo):

None provided

Duration of post- treatment incubation (in vitro):

None provided

Number of animals or in vitro replicates:

3

Details on study design:

Test article was applied into the conjunctival sacs of 3 rabbits. One eye in each was washed immediately after treatment, the other was unwashed.

Irritation parameter:

other: descriptive

Basis:

mean

Time point:

other: None provided

Remarks on result:

probability of moderate irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritant / corrosive response data:

The authors did not provide a numerical score. They stated that there was moderate irritation and that washing was slightly palliative.

Eye and skin irritation was conducted in 1980/1981, at the start of GLP. As a result, the reports are generally under-reported, as standards for report content had not yet been set. The report exists as more of a short summary of the findings, while the primary details of the conduct were kept in generic standard operating proceedures that were applicable to each type of study. As such, individual numeric evaluations were not available for these tests, and the results are reported out in a more general qualatative description. The values for the results provided here are not real and are only placeholders as TCC demanded some sort of entry, even if one was not available.

The laboratory where this work was conducted was the state of the art at the time, and was one of the top labs in the world. We have no reason to doubt the results of the studies, but the findings are not reported out in such way that they are very applicable to entry as a robust summary today.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

The results of the eye and skin irritation study support a category 2 classification for both.