Benzoic acid, 4-hydroxy-, docosyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline- and GLP-Study with no deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

docosyl 4-hydroxybenzoate

EC Number:

920-338-0

Cas Number:

109236-76-2

Molecular formula:

C29 H50 O3

IUPAC Name:

docosyl 4-hydroxybenzoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test Animals: Healthy New Zealand White Rabbits Hsdlf: NZW, body weight at the beginning of the study > 2 kg.
Source: Harlan Winkelmann GmbH, D-33178 Borchen

Three female animals were used. The animals were derived from a controlled full barrier maintained breeding system (SPF).
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Animal Husbandry:
Semi-barrier in an air conditioned room
- Temperature: 18 ± 3°C (recommendations of TVT, GV-SOLAS; see References)
- Relative humidity: 55 + 10%
- Artificial light, sequence being 12 hours light, 12 hours dark Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days)

Preparation of the Animals:
Approximately 24 hours before the test, fur from animal no. 1 was removed from the dorsal area of the trunk by clipping. Approximately 23.5 hours before the test, for from animals no. 2 and 3 was removed from the dorsal area of the trunk by clipping.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: The untreated flank of the animals.

Amount / concentration applied:

The test item was applied as a single dose to a small area (approx. 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.

Duration of treatment / exposure:

Test item was held in contact with the skin throughout a 4-hour period. The test item moistened with aqua ad inject.

Observation period:

The animals were examined for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours.

There were no significant body weight changes during the contact and observation period. The Primary Irritation Index (PII) was 0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the reported data of this irritation study it can be stated that the test item 4-Hydroxybenzoic acid behenylester showed no irritant/corrosive effects. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) and the GHS (Globally Harmonised System of Classification and Labelling of Chemicals) the test item 4-Hydroxybenzoic acid behenylester does not have to be classified and has no obligatory labelling requirement for skin irritation.