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Toxicological information

Eye irritation

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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 the test chemical in humans
Author:
Danilel J. Dire et al.
Year:
1987
Bibliographic source:
Journal of Toxicology: Clinical Toxicology, 1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Eye irritation potential of the test chemical was assessed by exposing the individuals through acute inhalation route.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 the test chemical to be irritating to eyes.
Acute exposure to the test chemical caused irritation to the eyes of humans.
Executive summary:

The study reports the evaluation of 17 patients who were exposed to aerosolized test chemical.

Approximately 10 lbs =(4.53kg) 4530000mg of 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 test chemical 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 test chemical may be considered as irritating to eyes.