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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to OECD guidance 405 and to GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
EC Number:
271-653-9
EC Name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
Cas Number:
68603-38-3
IUPAC Name:
68603-38-3
Details on test material:
CAS name: Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24/48/72 h (mean)
Score:
ca. 2
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24/48/72 h (mean)
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24/48/72 h (mean)
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: (animal #2: reversible withing 7 days)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 h (mean)
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: (in animal #1 - other animals: reversible)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 h (mean)
Score:
ca. 2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: (in animal #1 - other animals: reversible)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Irreversible damage to the eye, which was not reversible within 21 days, occurred in animal #1 and #3. Therefore, the substance falls under GHS category 1 (serious eye damage).
Executive summary:

In a study according to OECD 405 and under GLP conditions, three rabbits were treated with a single dose of 0.1 mL of the undiluted substance for 24 hours. The untreated eye served as a control. After the exposure, the eyes were rinsed and stained with fluoresceine. All symptoms were reported for a period of 21 days after application. On the basis of the irreversible damage in animals #1 and #3 that was persistent after 21 days, the substance has to be classified as GHS Cat. 1 with regard to eye irritation.