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Diss Factsheets

Administrative data

Description of key information

- Patch test for primary skin irritation and corrosivity - Rabbit - (study report 1977 (not irritating)

- Acute Eye Application - Rabbits - (study report 1977) (corrosive)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: The Federal Hazardous substances Act (code of Federal Regulations, Title 16, Chapter II, 1976)
Principles of method if other than guideline:
- Principle of test:0.5 gram of the test substance was applier on the trunk of 6 rabbit for 24 hours on intact or abraded skin.

GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of undiluted sample which was moistened with physiological saline to form a paste was applied under a one inch-square surgical gauze patch.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 albino rabbits
Details on study design:
TEST SITE
- Area of exposure: Two layers thick (an intact skin area and an abraded skin area). The application sites were prepared by clipping the hair from the saddle area of the rabbits.The abraded areas were prepared by making minor epidermal incisions with a hypodermic needle. The abrasions, were sufficiently deep to penetrate the epidermis but not to induce bleeding.
- % coverage: no data
- Type of wrap if used: the trunk was wrapped with rubbe. An outer layer of gauze and tape was placed around the trunk of the animals.

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
- Method of calculation: similar to Draize score.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72 hours
Score:
0
Reversibility:
other: Not applicable as no effect
Irritant / corrosive response data:
No irritative or corrosive effects were noted at either observation period. The Primary irritation Index was found to be 0.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, no irritation was observed on skin rabbit after a 24-hour exposure period.
Executive summary:

This study was conducted to evaluate the primary skin irritative potential of Benzyltriphenylphosphonium chloride. Five-tenths of the undiluted sample was moistened with physiological saline to form a paste was applied under a one inch-square surgical gauze patch, two layers thick, to an intact skin area and an abraded skin area on each of six albino rabbits. The application sites were prepared by clipping the hair from the saddle area of the rabbits. The abraded areas were prepared by making minor epidermal incisions with a hypodermic needle. The abrasions, were sufficiently deep to penetrate the epidermis but not to induce bleeding. Each patch was held in place with two strips of one-inch adhesive tape. After application of the patches, the trunk of each rabbit was wrapped with rubbe and secure with staples. An outer layer of gauze and tape was placed around the trunk of the animals. The animals were restrained in Newmann harnesses for 24 hours. No irritative or corrosive effects were noticed at either observation period. The Primary Irritative Index was found to be 0. Based on results from this test, no classification is required for Benzyltriphenylphosphonium Chloride.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data (during the year 1977)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: The Federal Hazardous substances Act (code of Federal Regulations, Title 16, Chapter II, 1976)
Principles of method if other than guideline:
- Principle of test:One-tenth gram of undiluted test substance was applied to the left eye of each six albino rabbits. The right eyes were untreated and served as controls.
- Parameters analysed / observed: corneal, iris and conjunctival effects were scored separately.
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 94F-015
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No data
Vehicle:
unchanged (no vehicle)
Controls:
other: the right eyes served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 gram
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing

SCORING SYSTEM: similar to Draize scoring

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.66
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: unable to score due to opacity and swelling
Irritant / corrosive response data:
Within 24 hours following application, the sample produced mortality in five rabbits. Irritative effects in the surviving rabbit at the 24-hour reading included moderate cornea. the effects observed were conjunctivitis, and diffuse areas of blanching in the conjunctivae and entire nictitating membrane. Irritative effects increased slightly by the 72-hour reading. Iritis could not be scored at the 72-hour reading due to severe corneal opacity.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this test, the test substance is considered as corrosive.
Executive summary:

Eye irritation of benzyltriphenylphosphonium chloride was evaluated in rabbit. Six albino rabbits receives application of 0.1 g of test substance to an unwashed eye. Five to six animals died within 24 hours. In the surviving rabbit, severe swelling and opacity was seen in iris, cornea, and conjunctivae, with discharge, erythema, and blanching of the conjunctivae at 72 hours. Under the conditions of this test, the test substance is classified as corrosive (Eye Corr. 1; H318).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Justification for classification or non-classification

In vivo observations warrant classification as Eye Dam. 1, H318.

Based on the eye irritation study in rabbits where 5/6 rabbits died within 24 hours following the ocular instillation of 0.1 g, Acute Dermal Toxicity cat. 3, H311 classification is also applied, as well as the non-GHS EUH070 ("Toxic by eye contact") hazard statement.