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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
acute oral toxicity test
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Holtzman
Sex:
male
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
not stated
No. of animals per sex per dose:
no data
Control animals:
not specified
Sex:
male
Dose descriptor:
LD50
Effect level:
> 9 040 mg/kg bw
Conclusions:
Under the conditions of this study the LD50 in rats was >9040 mg/kg bw.
Executive summary:

Male Holtzman rats (number unspecified) were exposed orally to a single dose of the test substance. The LD50 was > 9040 mg/kg bw (Emery Industries, 1969).

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
acute dermal toxicity test
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
other: albino (not further specified)
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
not stated
Doses:
maximum dose: 9.04 g, other doses not stated
No. of animals per sex per dose:
no data
Control animals:
not specified
Dose descriptor:
LD50
Effect level:
> 9 040 mg/kg bw

Local irritation of undiluted material: erythema and oedema, followed by  desquamation, coriaceousness, and fissuring of the skin. These effects were more marked in the highest dose group.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the dermal LD50 was > 9.04 g/kg bw. The single application was irritating to the skin.
Executive summary:

The dermal LD50 in albino rabbits was > 9.04 g/kg bw (no further details). The exposure was irritating to the skin, causing erythema and edema, initially followed by desquamation, coriaceousness and fissuring (Emery Industries, 1969).

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
testing for irritation/corrosion of the skin
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
no data
Observation period:
no data
Number of animals:
no data
Irritant / corrosive response data:
Dermal irritation was produced, characterized by erythema and edema initially followed by desquamation, coriaceousness, and fissuring. These signs were more marked in the highest dosage group.
Conclusions:
Data presented in this report are insufficient for a definite interpretation of the results.
Executive summary:

Testing for irritation of the skin in rabbits with the undiluted test item (EMFAC 1202 Pelargonic acid) produced dermal irritation increasing with dosage (Emery, 1969).

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1969
Report date:
1969
Reference Type:
publication
Title:
Unnamed
Year:
1944
Report date:
1944

Materials and methods

Principles of method if other than guideline:
Method: testing for irritation of the eye
Scoring according to Draize et al., 1944
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonanoic acid
EC Number:
203-931-2
EC Name:
Nonanoic acid
Cas Number:
112-05-0
Molecular formula:
C9H18O2
IUPAC Name:
nonanoic acid
Details on test material:
- Name of test material (as cited in study report): EMFAC 1202 Pelargonic acid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Amount applied: 91 mg
Duration of treatment / exposure:
not stated
Observation period (in vivo):
do data
Number of animals or in vitro replicates:
no data
Details on study design:
Comment: not rinsed

SCORING SYSTEM:
- In this report of Emery (1969) it is stated that the evaluation of the eye injury data was based upon the method of Draize. The authors refer to an unpublished reference of the "Association of Food and Drug Officials of the United States". As the presentation of the results by Emery (1969) is in accordance with the scoring system presented by Draize et al. (1944), it is assumed that this scoring system was the basis for the evaluation of the ocular lesions. The scoring system of Draize et al. (1944) is presented below. The scores are comparable to the scores of the OECD TG 405.
- Readings usually made at 1, 24 and 48 hours after instillation of the agent into the eye as well as after 96 hours if residual injury is present.

Results and discussion

Any other information on results incl. tables

"Marked irritation": iritis, conjunctivitis, corneal opacity. No further  data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Data presented in this report are insufficient for a definite interpretation of the results.
Executive summary:

The test item was applied to the eyes of albino rabbits and produced marked irritation, including signs as iritis, conjunctivitis and corneal opacity (Emery, 1969).