Dibenzoyl-L-tartaric acid monohydrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24/03/1986 - 30/04/1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dibenzoyl-L-tartaric acid monohydrate

EC Number:

220-374-0

EC Name:

Dibenzoyl-L-tartaric acid monohydrate

Cas Number:

2743-38-6

Molecular formula:

C18H14O8

IUPAC Name:

(2R,3R)-2,3-bis(benzoyloxy)butanedioic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FR G
- Weight at study initiation: 3.04 kg (males), 3.33 (female).
- Housing: 1 animal per cage; cages made of stainless steel with wire mesh walk floors, floor area 40x51cm. No bedding, sawdust in the waste trays.
- Diet: KLIBA 341, 4 mm; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND. About 130 g per animal per day.
- Water: about 250 ml tap water per animal per day.
- Acclimation period: at least 8 days in the same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): not specified, animals were housed in fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 /12 (6.00 - 18.00 h / 18.00 - 6.00 h)

IN-LIFE DATES: From: 24.03.86 To: 29.03.86 (necropsy)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

at least 15h before start of the study.

Vehicle:

water

Remarks:

50% (w/w) aqueous formulation.

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the test patch is covered with an about 0.5 mm layer of the test item suspension.
- Concentration (if solution): 50% (w/w)

NEGATIVE CONTROL
- untreated skin sites of the same animal.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

2 males, 1 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm, in the upper third of the back or flanks.
- Type of wrap if used: four layers of absorbent gauze + porous bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, removal with lutrol and lutrol/water (1:1).
- Time after start of exposure: at the end of the exposure period.

OBSERVATION TIME POINTS (indicate if minutes, hours or days)
- 30 - 60 min after removal of test patches, and 24, 48 and 72 h after application.
- additional examinations: if there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

SCORING SYSTEM:
- Evaluation of erythema (R) and edema (ED): 0 = none, 1 = very slight, 2 = well-defined, 3 = moderate to severe, 4 = severe
- Method of calculation: calculation of the mean according to 83/467/EEC criteria of July 29th, 1983 (for calculation of the means of erythema and edema only the readings of 24, 48 and 72 h are used).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No abnormalities were observed.

Any other information on results incl. tables

Table 1. Summary of results.

Animal No.	Code	Sex	Weight	Readings								mean		mean
				4 h		24 h		48 h		72 h
				R	ED	R	ED	R	ED	R	ED	R	ED	R	ED
1	0050	F	3.33	0	0	0	0	0	0	0	0	0	0	0	0
2	0077	M	3.00	0	0	0	0	0	0	0	0	0	0
3	0019	M	3.08	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU criteria.

Conclusions:

The test item is not irritant to the skin.

Executive summary:

The dermal irritation/corrosion of the test item was studied in vivo acorrding to OECD 404 (GLP study, certificate not available). 1 female and 2 male Vienna White rabbits were exposed to a 50% aqueous solution of the test item for 4h, and the responses were observed 4, 24, 48 and 72h after patch removal. Animals were necropsied at the end of the study. Erythema and edema scores were 0/4 at all time points, and no abnormalities were observed at necropsy. Therefore, the test item is not irritant to the skin.