Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-03-22 to 1967-04-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but obtained by standardised procedures comparable to those presently in use and thus valid for characterising the toxicity of the substance tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
other: BASF test, comparable to OECD 405, but eyes were not washed out after 24 h, standard readouts on workdays, and fluorescin was applied
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: N-Acetylmorpholin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3 kg (male); 3.05 kg (female)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1967-03-29 To: 1967-04-06

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control eye: left eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 mL of undiluted test item (corresponds to about 56 mg test item)

CONTROL MATERIAL
- Amount applied: 0.05 mL of "NaCl" (probably physiol. saline solution)
Duration of treatment / exposure:
not applicable - eye not rinsed after 24 hours
Observation period (in vivo):
8 days (readings at 1h, 24h, 48h and 8d after application)
Number of animals or in vitro replicates:
one male, one female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 h, 24 h, 48 h and 8d (mean)
Score:
0
Max. score:
3
Remarks on result:
other: No 72 h readout in raw data, but as no irritation occurred, data point not necessary for evaluation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU