Boronic acid, (4-ethylphenyl)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-10-16 to 2006-12-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(4-ethylphenyl)boronic acid

EC Number:

613-145-5

Cas Number:

63139-21-9

Molecular formula:

C8 H11 B O2

IUPAC Name:

(4-ethylphenyl)boronic acid

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: Approx. 7 to 11 weeks
- Weight at study initiation: Range from 214 to 244 g (mean: 230 g)
- Housing: Separately in type IE Makrolon cages with a shelter and softwood granulate as bedding.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 48 to 66
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Day 0 To: Day 14

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

paraffin oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap: Gauze patch + self-adhesive fabric

REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test material was wiped off.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 3.52 g test item preparation/kg bw
- Concentration: 569 g/L
- Constant volume or concentration used: Yes

VEHICLE
- Lot/batch No: K32250274 333

Duration of exposure:

24 hours

Doses:

- 2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: Yes
- Other examinations performed: All animals were subjected to a gross pathological investigation.

Statistics:

Not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in the 5 male and 5 female rats after dermal treatment with 2000 mg/kg of the test item.

Gross pathology:

At necropsy, no organ alterations were seen.

Any other information on results incl. tables

Table 1: Individual body weights in grams

			Day
Dose	Sex	Animal No	1	2	4	6	8	11	13	15
2000 mg/kg bw	male	1	244	236	248	259	273	291	296	312
	male	2	220	206	217	224	234	246	249	256
	male	3	233	231	244	260	269	285	295	303
	male	4	240	238	247	256	270	285	292	302
	male	5	243	235	251	264	275	292	300	311
	female	6	220	218	226	226	233	235	233	241
	female	7	227	208	226	221	229	232	234	236
	female	8	235	220	221	235	226	236	236	242
	female	9	224	224	230	233	238	242	232	239
	female	10	214	204	210	217	218	218	227	224
	male	N	5	5	5	5	5	5	5	5
		Mean	236	229	241	253	264	280	286	297
		Gain (%)	****	-3	2	7	12	19	21	26
	female	N	5	5	5	5	5	5	5	5
		Mean	224	215	223	226	229	233	232	236
		Gain (%)	****	-4	-1	1	2	4	4	6

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg bw after dermal application to rats.

Executive summary:

The test material was tested for acute toxicity in 5 male and 5 female rats after dermal administration of 2000 mg/kg body weight. Directly before administration, the test material was moistened with liquid paraffin, spread on the shaven skin in an area of 6 x 6 cm, and covered with a gauze patch. This was kept in place by a self-adhesive fabric. The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully. No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The body weight development was inconspicuous. The gross pathological examination revealed no organ alterations.