3-(3-tert-butyl-4-hydroxyphenyl)propionic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Mar. 3, 1988 to May 5, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guideline, with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(3-tert-butyl-4-hydroxyphenyl)propionic acid

EC Number:

403-920-4

EC Name:

3-(3-tert-butyl-4-hydroxyphenyl)propionic acid

Cas Number:

107551-67-7

Molecular formula:

C13H18O3

IUPAC Name:

3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd. Animal Production 4332 Stein / Switzerland.
- Age at study initiation: 7 to 8 weeks.
- Weight at study initiation: 220 to 248 g.
- Housing: The rats, segregated by sex, were individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin).
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 5 days before application.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C.
- Humidity (%): 55 ± 10%.
- Air changes (per hr): Approximately 15 air changes per h.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

peanut oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of the rat.
- % coverage: At least 10% of the body surface.
- Type of wrap if used: was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm water.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg body weight.
- Concentration (if solution): 2000 mg/kg body weight.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

5 per sex.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Mortality: Daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: Daily.
Body weight: At start and on Days 7 and 14.
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.
- Necropsy of survivors performed: Yes.

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality.

Clinical signs:

other: Ruffled fur, dyspnea, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, reduced spontaneous activity was observed during the application day and Day 1 after application. The animals recovered within 10 days. Ref

Gross pathology:

No deviations from normal morphology were found.

Other findings:

Not available.

Any other information on results incl. tables

Table 1 Signs and symptons

observations

Exposure day: hours

Days of post-exposure period

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

2000 mg/kg males

ruffled fur

X

X

X

X

X

X

X

X

X

X

X

X

X

dyspoea

X

X

X

X

X

X

X

X

X

X

hunched post.

X

X

X

X

ventr.recumb.

X

X

X

X

X

red.spot.act.

X

X

X

X

X

2000 mg/kg females

ruffled fur

X

X

X

X

X

X

X

X

X

X

X

X

X

dyspoea

X

X

X

X

X

X

X

X

X

X

hunched post.

X

X

X

X

ventr.recumb.

X

X

X

X

X

red.spot.act.

X

X

X

X

X

Table 2 Mean body weight and standard deviation

	Males			Females
Dose (mg/kg)	Day 1	Day 7	Day 14	Day 1	Day 7	Day 14
2000	240/ 9.4	278/16.3	310/23.2	233/ 7.7	246/10.0	256/ 7.8

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single dermal administration of the test substance (OECD guideline 402) to rats did neither induce mortalities nor adverse effects. LD50 is considered to be > 2000 mg/kg bw.