Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1989-02-14 to 1989-05-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, individual data on conjuntival effects missing (last page of report, page 11, is missing)

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecanedioic acid

EC Number:

211-746-3

EC Name:

Dodecanedioic acid

Cas Number:

693-23-2

Molecular formula:

C12H22O4

IUPAC Name:

dodecanedioic acid

Details on test material:

Dodecanedioic acid of Hüls AG, purity ca. 99 %;
impurities: homologous dicarboxylic acids, total 1 %

Test animals / tissue source

Species:

rabbit

Strain:

other: Small white Russian, Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male 
- Number of animals: 6 males
- Controls: untreated eye
- Weight at study initiation: 2.1-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

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

IN-LIFE DATES: From: 14.02 1989 To: 17.05.1989

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

ADMINISTRATION/EXPOSURE 
- Concentration: undiluted
- Amount applied: 0.1 g
- Preparation of test substance: grinding in mortar
- Vehicle: none
- Postexposure observation period: 13 days

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

- Postexposure observation period: 13 days

Number of animals or in vitro replicates:

6

Details on study design:

Comment: rinsed after 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 7, 8, 10 and 13  days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.44

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72h

Score:

2.5

Reversibility:

fully reversible

Remarks on result:

other: erythema

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72h

Score:

1.06

Reversibility:

fully reversible

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.44
- Conjunctivae (Redness): 2.50
- Conjunctivae (Chemosis): 1.06
- Overall irritation score: 11.96/110

Other effects:

REVERSIBILITY: complete within 10 days
OTHER EFFECTS: There were no indications of mechanical irritation by the  finely ground solid test material. Conglutination of eyelids was observed 
in the males at 24 or at 48 hours.

Any other information on results incl. tables

    no effects on cornea                                                                                           

Animal No	Iris, Observation time
	1 h	24 h	48 h	72 h	6-13 days
57889	1	0	0	0	0
58051	1	0	0	0	0
58057	1	1	1	0	0
70115	1	1	0	0	0
70293	1	1	1	1	0
70327	1	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008

Conclusions:

In this study, dodecanedioic acid the read-across for Corfree M1 was an eye irritant.

Executive summary:

In a primary eye irritation study 0.1 g of dodecanedioic acid was instilled into the conjunctival sac of the right eye of six male young adult White Russian rabbits. Animals then were observed for 13 days. 

Cornea were not affected. Iris was very mild and reversibly affected. Chemosis and erythema were recorded for conjunctival effects, mean score (24 -72h) was 2.5 for iridal redness. Eyes were normal with 1 - 7 days. In this study, dodecanedioic acid was an eye irritant..