[Name confidential or not available]

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:

Study in-life phase Start : 15 April 2013 Completion : 25 April 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP Guideline study without deficiencies. Alkylated Naphthalene, EC Number 700-826-8 is a close structural analog of alkyl naphthalene. The substances have similar chemical and physical properites and the irritation studies for Alkylated Naphthalene, EC Number 700-826-8 can be used as read-across to alkyl naphthalene.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Description: Clear amber slightly viscous liquid
Batch: 18515
Purity: 100% UVCB

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: Albino rabbit, New Zealand White, (SPF-Quality).

Source: Charles River France, L’Arbresle Cedex, France
Number of animals 3 Males.
Age and body weight Animals used within the study were between 12 and 24 weeks old and body weights were at least 1.5 kg.
Identification Earmark.
Health inspection At least prior to dosing. It was ensured that the animals were healthy and that the eyes were free from any abnormality.

Animal husbandry
Conditions:
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm). Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

Each animal was treated by instillation of 0.1 mL of the test substance, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
In order to provide a continued level of systemic analgesia, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg were administered by subcutaneous injection following the 24 hours observation. After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20%
(AST Farma BV, Oudewater, The Netherlands).

Observations:
Mortality/Viability Twice daily.
Toxicity At least once daily.
Body Weight Day of treatment (prior to instillation) and after the final observation.
Necropsy No necropsy was performed according to protocol.
Irritation The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24

Score:

ca. 0

Max. score:

8

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48

Score:

ca. 0

Max. score:

8

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72

Score:

ca. 0

Max. score:

8

Irritant / corrosive response data:

Instillation of 0.1 mL of alkylated naphthalene into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours. No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
There was no evidence of ocular corrosion.

Other effects:

No mortality or clincal symptoms

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Alkylated naphthalene is not irritating or corrosive to the eye.

Executive summary:

An acute eye irritation/corrosion study was conducted with alkylated naphthalene in the rabbit. The study was carried out based on the guidelines described in: OECD No.405 (2012) "Acute Eye Irritation / Corrosion". Single samples of 0.1 mL of alkylated naphthalene were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours. No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. There was no evidence of ocular corrosion. Based on these results, alkylated naphthalene does not have to be classified and has no obligatory labeling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures including all amendments.