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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
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 is from peer-reviewed journal

Data source

Reference
Reference Type:
publication
Title:
ACUTE EXPOSURE TO RHODAMINE B
Author:
Daniel J. Dire & Joseph A. Wilkinson
Year:
1987
Bibliographic source:
CLINICAL TOXICOLOGY, 2 5 ( 7 ) , 603-607 (1987)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute inhalation testing was conducted in individuals exposed through rhodamine B aerosols.
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no

Test material

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
Rhodamine B
IUPAC Name:
Rhodamine B
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Rhodamine B
- Molecular formula (if other than submission substance): C28-H31-N2-O3.Cl
- Molecular weight (if other than submission substance): 479.017 g/mole
- 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 (if other than submission substance): C28-H31-N2-O3.Cl
- Molecular weight (if other than submission substance): 479.017 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
other: Human
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at study initiation: 16 males of mean age 39 years (25-50) and one female 40 year old.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remark on MMAD/GSD:
not specified
Details on inhalation exposure:
26 minutes exposure to aerosolized Rhodamine B
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
26 min
Remarks on duration:
not specified
Concentrations:
No data available
No. of animals per sex per dose:
17
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
other: EC
Effect level:
4 530 000 other: mg
Based on:
test mat.
Remarks on result:
other: effect on clinicla sign
Mortality:
No data available
Clinical signs:
other: Burning of eyes, Excessive tearing, Nasal burning and etching, pain/Tightness in Chest, Rhinorhea, Cough, Dyspnea, Burniing of throat, Burning/Pruritic skin, Chest Burning, Headache and Nausea was observed in exposed patients.
Body weight:
No data available
Gross pathology:
No data available
Other findings:
not specified

Any other information on results incl. tables

Symptoms

Number o f Patients

Percent

Burning of eyes

14

82%

Excessive tearing

8

47%

Nasal burning

7

41%

Nasal etching

6

35%

Chest pain/Tightness

5

35%

Rhinorhea

5

29%

Cough

5

29%

Dyspnea

5

29%

Burniing of throat

4

24%

Burning/Pruritic skin

4

24%

Chest Burning

2

12%

Headache

1

6%

Nausea

1

6%

No symptoms

1

6%

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Conclusions:
The most frequent symptoms were ocular and upper respiratory tract mucous membrane irritation. But all the symptoms resolved in 24 hours .No serious effects observed .Based on this the Effect concentration could be reported as approx (4.53kg) 4530000mg.
Executive summary:

Approximately 10 lbs=4.53kg 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. 16 out of 17 of the patients (94%) complained of symptoms which are - 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 of the eyes which occurred in 83% of the patients . Four of the patients (24%) were placed on humidified oxygen because of respiratory symptoms. Five o f the patients (29%) underwent irrigation of their eyes secondary to eye burning. After being discharged from the hospital and follow up is 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. No serious effects observed .Based on this the Effect concentration could be reported as approx (4.53kg) 4530000mg.