Cyclohexane-1,2-dicarboxylic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA

Principles of method if other than guideline:

24 hour exposure period on abraded and intact skin. Treated sites examined for reaction to treatment 24 and 72 hours following exposure.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexane-1,2-dicarboxylic anhydride

EC Number:

201-604-9

EC Name:

Cyclohexane-1,2-dicarboxylic anhydride

Cas Number:

85-42-7

Molecular formula:

C8H10O3

IUPAC Name:

octahydro-2-benzofuran-1,3-dione

Test material form:

solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 10 496

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 12 - 15 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: Individually caged
- Diet (e.g. ad libitum): Styles-Oxoid commercial rabbit diet, ad libitum
- Water (e.g. ad libitum): Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 50% (aq) polyethylene glycol

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 mL (500 mg test substance)
- Concentration (if solution): 10 g test substance mixed with 11 mL 50% (aq) polyethylene glycol

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours an 6 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Test sites: One abraded, one intact site / animal
- Type of wrap if used: Gauze pad covered with aluminium foil held in place by self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Intact skin

Remarks:

FHSA test - observations at 24 and 72 hours only

Any other information on results incl. tables

Intact skin
Animal No.	Erythema		Oedema
	24 hours	72 hours	24 hours	72 hours
11 M	0	0	1	0
13 M	0	0	0	0
15 M	0	0	1	0
12 F	0	0	2	0
14 F	0	0	0	0
16 F	0	0	0	0
Mean	0.0		0.33

 

Abraded skin
Animal No.	Erythema		Oedema
	24 hours	72 hours	24 hours	72 hours
11 M	1	0	2	1
13 M	1	0	0	0
15 M	1	0	1	0
12 F	0	0	2	0
14 F	1	0	0	0
16 F	1	0	1	0
Mean	0.42		0.58

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

Primary skin irritation has been investigated according to FHSA test methods. The substance was slightly irritating to the skin of the albino rabbit.

Executive summary:

Primary skin irritation has been investigated according to FHSA test methods with 24 hours exposure to intact and abraded skin. The substance was slightly irritating to the skin of the albino rabbit.

Exposure was for a 24 hour period in contrast with 4 hours required by current OECD/EU test methods. However, the information obtained clearly demonstrate the substance to be only slightly irritating and classification as a skin irritant would not be required under the EU/GHS classification scheme.