3,7-bis(diethylamino)phenoxazin-5-ium acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Acute exposure to Rhodamine B

Author:

Daniel J. Dire & Joseph A. Wilkinson

Year:

1987

Bibliographic source:

Journal of Toxicology: Clinical Toxicology, 25:7, 603-607; 1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Eye irritation potential of rhodamine B was assessed by exposing the individuals through acute inhalation route.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride

EC Number:

201-383-9

EC Name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride

Cas Number:

81-88-9

Molecular formula:

C28H31N2O3.Cl

IUPAC Name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Rhodamine B
- Molecular formula : C28H31N2O3.Cl
- Molecular weight : 479.017 g/mol
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Rhodamine B
- Molecular formula : C28H31N2O3.Cl
- Molecular weight : 479.017 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Age at study initiation: 16 males of mean age 39 years (25-50) and one female 40 year old.

Test system

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

4530000 mg

Duration of treatment / exposure:

26 min

Observation period (in vivo):

24hrs

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

17 individuals

Details on study design:

Not applicable

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Burning of the eyes (82%), excessive tearing (47%), nasal burning (41%), nasal itching (35%), chest pain/tightness (35%), rhinorhea (29%), cough (29%), dyspnea (29%), burning of the throat (24%). burning/ pruritic skin (24%), chest burning (12%), headache (6%), and nausea (6%).

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

14 patients indicated 82 % eye irritation at the dose of approx (4.53kg) 4530000mg of dose indicating Rhodamine B to be irritating to eyes.
Acute exposure to Rhodamine B caused irritation to the eyes of humans.

Executive summary:

The study reports the evaluation of 17 patients who were exposed to aerosolized Rhodamine B.

Approximately 10 lbs =(4.53kg) 4530000mg of Rhodamine B powder was spilled onto the floor of a vehicle maintenance shop. A cleanup crew began to sweep up the powder from the floor . This resulted in an aerosol of Rhodamine B dust that dispersed throughout the building contaminating the hair , skin, eyes, and clothing of most of the shop employees.

Sixteen o f the patients (94%) complained of symptoms such as redness, burning sensation..etc. One patient (6%) denied any symptoms despite being exposed to the dust for 15 minutes without a surgical mask. The most frequently reported symptom was burning o f the eyes which occurred in 82% of the patients . Four of the patients (24%) were placed on humidified oxygen because of respiratory symptoms. Five of the patients (29%) underwent irrigation of their eyes secondary to eye burning.

After being discharged from the hospital, follow up was maintained. Ten of the patients (59%) reported that their symptoms had resolved within 4 hours of their exposure to the dust. One patient (6%) reported that his symptoms lasted 12 hours and 2 patients (12%) reported their symptoms lasted 24 hours. Three of the patients (18%) could not remember the duration of their symptoms.

Burning of eyes was observed in 82% of the patients. Based on these effects Rhodamine B may be considered as irritating to eyes.