Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-03-22 to 1967-04-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but scientifically fully acceptable.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
other: BASF test (close to Draize test), occlusive, 3 rabbits, intact skin, 20 h exposure (among others)
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.83 kg (male); 3.10 kg (female); 2.72 kg (male)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1967-03-29 To: 1967-04-14

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted (2 mL / animal (corresponds to 2.23 g)
Duration of treatment / exposure:
1, 5 or 20 minutes
20 hours (data selected as worst case for 4 h test)
Observation period:
Animal 1 (male, 7.6.645): 8 days, (day 3 and 4 lacking)
Animal 2 (female, 6.6.571): 5 days, (day 3 and 4 lacking)
Animal 3 (male, 5.6.427): 3 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: at six sites per rabbit along the dorsum (plus left ear, not considered)
- % coverage: approximately 6 cm2 each


REMOVAL OF TEST SUBSTANCE
- Washing: yes, mild detergent (50% Lutrol)


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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h, 48 h and 5 days (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h (mean)
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h, 48, 72 h (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20 h (instead of 4 h, OECD 404)
Irritant / corrosive response data:
not irritating (minimal signs of skin irritation (erythema grade 1) were noted after the 20 h exposure period in one animal at the 24h and 48h reading).

Applicant's summary and conclusion

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