5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1-nonanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989-04-18 to 1989-05-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

For read-across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

67989-23-5 (former CAS No.)

IUPAC Name:

67989-23-5 (former CAS No.)

Details on test material:

- Name of test material (as cited in study report): Witamol 218
- Physical state: liquid

- Nominal molecular formula (if other than submission substance): C35 H58 O6
- Nominal molecular weight (if other than submission substance): 574.85
- Nominal Smiles notation (if other than submission substance): O=C(c1ccc(cc1C(=O)O)C(=O)OCCCCCCCC)OCCCCCCCCCC
- Nominal InChl (if other than submission substance): 1S/C27H42O6/c1-3-5-7-9-11-12-14-16-20-33-27(31)23-18-17-22(21-24 (23)25(28)29)26(30)32-19-15-13-10-8-6-4-2/h17-18,21H,3-16,19-20H2,1-2H3, (H,28,29)

Test animals

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 10 x 10 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals, application of the test substance on a skin area of approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.56
- Edema: 0.11
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. Allanimals were free of symptoms after 6 - 8 days.

Other effects:

scurf formation in one animal

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/2/1	0/1/0
24 h	1/2/2	0/0/1
48 h	1/2/2	0/0/0
72 h	1/2/1	0/0/0
Average 24h, 48h, 72h	1.56	0.11
Reversibility*)	c.	c.
Average time (unit) for reversion	8 days	8 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. All animals were free of symptoms after 6 - 8 days.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed a slightly irritant effect on the skin of the test animals with a primary dermal irritation index (PDII) of 1.67/8. The average scores were as follows: Erythema: 1.56, Edema: 0.11

Executive summary:

Skin irritation of a structural analogue of the substance (1,2,4 -Benzenetricarboxylic acid, mixed decyl and octyl triesters) has been investigated in the rabbit using methods in accordance with OECD guideline 404 (12 May 1981).

The tested substance showed a slight irritating effect and the mean Irritation scores derived from the respective erythema and edema scores for the 24, 48 and 72 hours observations were 1.56 (erythema) and 0.11 (oedema).