Registration Dossier

Administrative data

Description of key information

In skin and eye irritation studies in rabbits no indication of irritation was observed.

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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Qualifier:
according to
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Principles of method if other than guideline:
Each of six adult (3 each M/F) New Zealand White rabbits were administered the test article and four skin sites – two abraded and two intact. Application sites were shaved. The skin was abraded using a 21-gauage burred needle; the abrasion penetrated the stratum corneum but not the dermis. Following the application of test material, one-inch square gauze patches were applied to each of the four sites. The animal’s trunk was then wrapped with a rubber dam and an Ace bandage to retard evaporation. The test substance was kept in contact with the skin site for 24 hrs. At the end of exposure, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and scored according to the Draize scale at 24 and 72 hrs after the test article was applied.
GLP compliance:
yes
Specific details on test material used for the study:
Saytex 42-77, Lot BR-3
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Individually caged. Light cycle: 12 hrs light, 12 hrs dark. Room temperature was 20 +/- 3 degrees C. Humidity was 30-70%.Annual testing of drinking water by Pennsylvania Gas and Water Company. Rabbits were fed Wayn Rabbit Ration ad libitum.
Type of coverage:
occlusive
Preparation of test site:
other: clipped & one side abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
o.5 mL/site
Duration of treatment / exposure:
24 hr
Observation period:
24 and 72 hr post-treatment
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: All
Score:
0.71
Max. score:
0
Reversibility:
other: not applicable

Rabbit

Number

Sex

Weight

(kg)

Observed Effects

24 Hours

72 Hours

Erythema

Edema

Erythema

Edema

Initial

Final

Intact

Abraded

Intact

Abraded

Intact

Abraded

Intact

Abraded

2744

2745

2746

2747

2748

2749

M
M
M
F
F
F

2.796

2.744

2.749

2.184

2.276

2.221

2.889

2.467

2.836

2.288

2.427

2.409

1-1

1-2

0-0

0-0

0-0

0-0

2-2

1-2

0-0

0-0

0-1

0-0

1-1

1-1

1-1

1-1

0-0

1-1

1-1

1-1

1-1

1-1

0-0

1-1

0-0

-

0-0

0-0

0-0

0-0

0-0

-

0-0

0-0

0-0

0-0

0-0

-

0-0

0-0

0-0

0-0

0-0

-

0-0

0-0

0-0

0-0

Totals

2-4

3-5

5-5

5-5

0-0

0-0

0-0

0-0

Mean Values Erythema/Edema

1.0

1.3

1.7

1.7

0.0

0.0

0.0

0.0

Total Erythema/Edema

2.3

3.4

0.0

0.0

Primary Irritation Index (Total/8)

0.71

0.0

One rabbit died on study (non-compound related).

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP was mildly irritating to the skin of rabbits.
Executive summary:

EBTBP (500 mg) was applied to the clipped abraded and intact skin of 6 albino rabbits. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr and the test site scored by the Draize method. The test site was also scored at 72 post-treatment. The test substance was considered to be a mild skin irritant.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Qualifier:
according to
Guideline:
other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, U.S. Federal Register, 38(187)P 27019, 27 Sept 1973
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Principles of method if other than guideline:
0.1 g instilled in one eye of each of 6 rabbits. test material not washed from eye. observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino rabbits
Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as own control
Amount / concentration applied:
0.1 gm in one eye of each rabbit
Duration of treatment / exposure:
test material not washed from eye
Observation period (in vivo):
observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: all scores at all time points were 0

Eyes observed for corneal opacity, iris, conjunctival redness and chemosis, and discharge.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP is not an eye irritatnt.
Executive summary:

EBTBP (100 mg) was instilled in the right eye of six albino rabbits. The treated eyes were observed at 1, 24, 48 and 72 hours and 5 and 7 days post treatment. No effects were observed at any time point in any animal with respect to the cornea, iris, or conjunctiva. The test article was not an eye irritant. 

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance did not induce skin or eye irritation in standard studies in rabbits. It is unlikely from these results that the substance is an respiratory irritant. The acute inhalation study did not show any signs of irritation to the respiratory tract.


Justification for selection of skin irritation / corrosion endpoint:
The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Justification for selection of eye irritation endpoint:
The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Justification for classification or non-classification

Due to the absence of skin and eye irritation in standard studies in rabbits, the substance is not classified for these endpoints.