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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 20-23, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD 404 guideline. GLP compliant. There were no significant deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
test control not performed
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Morpholine
- Physical state: clear colorless liquid
- Lot/batch No.: B-1-20
- Purity test date: responsibility of the Sponsor
- Stability under test conditions: responsibility of the Sponsor
- Other:amount submitted: 668.38g (test article and container)/pH:8 (paper indicator)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance,The Development Services Company, Denver, PA, USA
- Age at study initiation: 19-21 weeks
- Weight at study initiation: 2.710-3.278 kg
- Housing: rabbits were housed individually in stainless steel cages
- Diet: PMI Certified Lab Rabbit HF Diet
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-21°C
- Humidity: 25-70 %
- Photoperiod: 12 hours light/12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL/site

Duration of treatment / exposure:
3 min
Observation period:
3 and 55 min
Number of animals:
6 animals (3 males, 3 females)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk (clipped free of fur)

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 3 min

SCORING SYSTEM:
Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2/6
Time point:
other: immediate after exposure
Score:
>= 2
Max. score:
4
Remarks on result:
other: well-defined erythema
Irritation parameter:
erythema score
Basis:
animal: 4/6
Time point:
other: immediate after exposure
Score:
>= 1
Max. score:
4
Remarks on result:
other: very slight erythema
Irritation parameter:
edema score
Basis:
animal: 3/6
Time point:
other: immediate after exposure
Score:
>= 1
Max. score:
4
Remarks on result:
other: very slight edema
Irritation parameter:
edema score
Basis:
animal: 3/6
Time point:
other: immediate after exposure
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 55min
Score:
>= 4
Max. score:
4
Remarks on result:
other: severe erythema, necrosis
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 55min
Score:
>= 4
Max. score:
4
Remarks on result:
other: severe edema, necrosis
Irritant / corrosive response data:
In all animals severe etyhema, severe oedema and necrosis was observed after 55 min.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: DOT Classification (Packaging group I)
Conclusions:
Morpholine was considered to be a severe irritant. The test article was considered corrosive according to the DOT Classification (Packaging group I).
Executive summary:

In this primary dermal irritation study (Huntsman, 1997), 0.5 mL of Morpholine was applied to one site on the clipped dorsal trunk of 6 New Zealand White rabbits (3 males and 3 females) for an exposure period of 3 minutes. Observations for responses were recorded immediately after unwrap and at 55 minutes. Grading of irritation was performed according to the method of Draize. Following an exposure period of 3 minutes, severe erythema, severe oedema and necrosis were observed. Therefore, Morpholine was considered to be a severe irritant and was considered as corrosive according to DOT classification (Packaging group 1).

This study is classified as acceptable. It satisfies the requirements of OECD test guideline 404.