p-anisic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Oral (equivalent or similar to OECD 401), rat: LD50 > 5000 mg/kg bw

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

A reliable study regarding acute oral toxicity is available for the test substance. The acute oral toxicity of the test substance was assessed in a study performed equivalent or similar to OECD Guideline 401 (Bayer, 1979). Two groups of 10 male Wistar rats were treated with the test material at dose levels of 3100 and 5000 mg/kg bw. The test material was administered by gavage using peanut oil as vehicle. The animals were observed for 14 days. At the high dose two animals died on day 4 and all animals showed clinical signs of toxicity (diarhoea and increased diuresis). Neither mortalities nor clinical signs were noted at 3100 mg/kg bw.

The acute oral LD50 value of the test material was therefore > 5000 mg/kg bw.

The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

- The test was conducted before guideline was adopted.

- Principle of test: the test substance was applied to one auricle (inner surface) of each of 2 rabbits under semi-occlusive conditions for 24 hours. After the exposition remaining test item was removed by washing. Observations were made at removal of test item, after 24, 48 and 72 h as well as 7 days after application

- Parameters analysed / observed: erythema, edema and eschar formation

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: single housing
- Diet: typal feeding, ad libitum
- Water: ad libitum

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Remarks:

; the test item was moistened with water before application

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg

Duration of treatment / exposure:

24 h

Observation period:

7 days
Reading time points: after washing, 24, 48 and 72 h and 7 days

Number of animals:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with water and soap
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
- after washing, 24, 48 and 72 h and 7 days

SCORING SYSTEM:
- the scoring system used for interpretation of the skin reaction was not specified

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

other: eschar formation

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

At none of the reading time points, reactions indicative of skin irritation were noticed.

Other effects:

- Adverse systemic effects: no systemic effects were reported.

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study, that was conducted prior to implementation of the current guidelines, the skin irritation potential of p-anisic acid was tested by semiocclusive application of the test substance to rabbit ears for 24 h. No skin reaction was noted at any reading time point thus under the conditions of the test the compound was not a skin irritant.