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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, study predating OECD guideline, but scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Method based on Federal Register 38, No. 187, § 1500.41, S. 27019 (27.09.73)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylaminoethanol
EC Number:
203-797-5
EC Name:
2-ethylaminoethanol
Cas Number:
110-73-6
Molecular formula:
C4H11NO
IUPAC Name:
2-ethylaminoethanol
Constituent 2
Reference substance name:
110-73-06
IUPAC Name:
110-73-06
Test material form:
other: liquid
Details on test material:
No information

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
No details provided in study report

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
No detail given.
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system. Results originally reported according to BASF scoring system and transformed to scores according to OECD guideline 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Based on the available data, the test substance showed irreversible effects on the eyes of rabbits.
Marked corneal opacity was evident in all three rabbits, an effect on the iris was evident for all treated eyes while the iris was visible through the corneal opacity. Well defined conjunctival reactions including injection of the vasculature, diffuse crimson coloration and marked chemosis were evident in aeach ofthe treated eyes. The reactions were irreversible witin the 8 day observation period and indicate a severe ocular response that is consistent with the indications of dermal corrosivity observed in other studies.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of this study indicate that 2 -ethylaminoethanol is a severe eye irritant.
Executive summary:

In a standard, guideline-comparable assessment of primary ocular irritation three rabbits had undiluted test material instilled into the conjunctival sac, followed by an 8 day observation period during which ocular reactions werre assessed using the Draize scoring system.

Marked corneal opacity was evident in all three rabbits, an effect on the iris was evident for all treated eyes while the iris was visible through the corneal opacity. Well defined conjunctival reactions including injection of the vasculature, diffuse crimson coloration and marked chemosis were evident in each ofthe treated eyes. The reactions were irreversible witin the 8 day observation period and indicate a severe ocular response.