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Description of key information

The ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin.

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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary skin irritation study conducted using three male and three female rabbits. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Langshaw farms, Augusta, Michigan
- Housing: Individually housed in hanging wire-mesh cage
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-82
- Humidity (%): 37
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:
occlusive
Preparation of test site:
other: Intact skin and Abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5ml/test site
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 rabbits (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: Back of each rabbit
- Coverage: 20-30 % of the body surface
- Type of wrap if used: Guaze bandaging and Saran Wrap and over wrapped with several layers of 75 millimeter Elastoplast Tape. A collar was also applied to each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels.
- Time after start of exposure: Each test site was observed for skin irritation at 24 and 72 hours after test article application.

Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 Hours
Score:
0.5
Remarks on result:
other: Intact Skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.5
Remarks on result:
other: Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Remarks on result:
other: Abraded Skin
Irritant / corrosive response data:
Calculations for Primary Skin Irritation Score: 3.0/12 + 2.5/12=0.5 (Score: The average of all the erythema scores plus the average of all the edema scores)
Other effects:
Mortality:
None of the rabbits died during the 3-day study period.

Pharmacotoxic signs:
All of the animals appeared normal the 3-day study period, except for one male animal of the Intact group, which had diarrhea at 24 and 48 hours.

None

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the data obtained, the article TS2-16B Trimethyl borate, would not be considered a primary skin irritant.
Executive summary:

3 male and 3 female young adult New Zealand white rabbits were subjected to skin irritation test to evaluate the test substance, Trimethyl borate. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group.

24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels and observed for the next 72 hours for the following:

 

Primary Skin Irritation:

Each test site was observed for skin irritation at 24 and 72 hours after test article application.

 

Mortality:

The rabbits were observed twice daily (AM & PM) for mortality for a total of 3 days.

 

Pharmacotoxic signs:

The rabbits were observed for pharmacotoxic signs at 24 hours and once daily thereafter for a total of 3 days.

 

Body weights:

Body weights were obtained at study initiation (control) and study termination.

 

Based upon the data obtained (Primary Irritation Score = 0.5), the article TS2-16B Trimethyl borate, would not be considered a primary 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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Langshaw Farms of Augusta, Michigan
- Weight at study initiation: 2220 to 3115 grams
- Housing: Individually housed in hanging wire-mesh cage
- Identification: Ear tag
- Diet: Purina Certified Rabbit Chow, ad libitum
- Water: Ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64-82
- Humidity (%): 35-68%
- Photoperiod (12 hrs dark / 12 hrs light)

IN-LIFE DATES: From: November 8, 1979 To: December 13, 1979
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, undiluted
Duration of treatment / exposure:
Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.
Observation period (in vivo):
Observation period: 35 days
The unwashed group was terminated from the study on day 19.
Number of animals or in vitro replicates:
9
Details on study design:
Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights.
Irritation parameter:
cornea opacity score
Remarks:
Unwashed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 6.7 - <= 17.1
Max. score:
17.1
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Remarks:
Unwashed - Female
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 12.1 - <= 15.4
Max. score:
15.4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
Unwashed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 4.2 - <= 5
Max. score:
5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
Unwashed - Female
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 1.7 - <= 5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Unwashed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 12 - <= 14.7
Max. score:
14.7
Reversibility:
fully reversible within: 16 days
Irritation parameter:
conjunctivae score
Remarks:
Unwashed - Female
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 9.3 - <= 16.7
Max. score:
16.7
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Remarks:
Washed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 20 - <= 28.2
Max. score:
28.3
Reversibility:
not fully reversible within: 34 days
Irritation parameter:
cornea opacity score
Remarks:
Washed - Female
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
>= 5 - <= 7.5
Max. score:
7.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
Washed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 10 days
Irritation parameter:
iris score
Remarks:
Washed - Female
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
>= 2.5 - <= 5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Washed - Male
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
>= 15.5 - <= 18.5
Max. score:
18.5
Reversibility:
not fully reversible within: 34 days
Irritation parameter:
conjunctivae score
Remarks:
Washed - Female
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
>= 7 - <= 17
Max. score:
17
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
0.1 ml/right eye, unwashed - Primary eye irritant
0.1 ml/right eye, washed - Primary eye irritant
CLASSIFICATION
0.1 ml/right eye, unwashed -Moderately irritating
0.1 ml/right eye, washed - Moderately irritating
Other effects:
None

None

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Test material was evaluated as primary eye irritant and classified as moderatley irritating.
Executive summary:

Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second.

Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.

The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights. The observation period was of 35 days. The unwashed group was terminated from the study on day 19.

Based on the results, test material was evaluated as primary eye irritant and classified as moderately irritating.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Of the existing studies, the ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin. If current classification criteria are applied to the existing irritation scores for these trimethyl borate samples the classifications are unchanged.

Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights. The observation period was of 35 days. The unwashed group was terminated from the study on day 19. Based on the results, test material was evaluated as primary eye irritant and classified as moderately irritating.

Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that developed on the clipped skin of each of five albino rabbits within 24 hours of the uncovered application. Irritation on uncovered rabbit belly was scored to Grade 1 indiactive of no irritation.


Effects on eye irritation: moderately irritating

Justification for classification or non-classification

The ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin.

Additional studies to characterize the ocular and dermal irritation potential of trimethyl borate seem unnecessary; the data are sufficient for proper regulatory classification.