Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

NOAEC was considered to be 0.51 mg/l when Fischer 344 (F-344) CDF®[F-344]/CrIBR male rats were treated with phosphorus (3+) tribromide by Nose only vapor inhalation for4 hrs /day for 5 days.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
510 mg/m³
Study duration:
subacute
Species:
rat
Quality of whole database:
Data is Klimiach 4 and from Eastman Kodak Co
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Reproductive toxicity: Inhalation

In different studies, phosphorus (3+) tribromide has been investigated for reproductive toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments in rodents, i.e. most commonly in rats for phosphorus (3+) tribromide.

In a experimental study conducted Eastman Kodak Co (OTS0555394, Eastman Kodak Company, 1992), Subacute inhalation toxicity study, Fischer 344 (F-344) CDF®[F-344]/CrIBR male rats were treated with phosphorus (3+) tribromide in the concentration of 0, 0.06,0.16, 0.51 mg/L by Nose only vapor inhalation for4 hrs /day for 5 days. No mortality and signs of toxic stress were observed in treated male rats at 0.06, 0.16, 0.51 mg/L as compared to control. Significantly significant decrease in body weight was observed in0.51 mg/L treated male rats as compared to control. Similarly, Statistically significant decrease in Basophils level were observed in 0.05 mg/L and Statistically significant increased in calcium, potassium, Chloride and Potassium values and Decrease in alkaline phosphatase, creatine and ALT kinase were observed at 0.51 mg/L and Decrease in ALT and increase in Chloride values were observed as compared to control when treated with 0.16 mg/L. Additional statistically significant differences in mean values of serum chemistry or hematologic parameters were sporadic and were not considered biologically important. In addition, No statistically significant effect on Absolute and relietive Liver, Kidneys, Testes, Brain, Spleen, Adrenals, Lungs, Thymus and Heart weight were observed in treated rats compared to control. Irregular shaped and reddened nares in 3 male rats were observed at 0.51 mg/L and no gross pathological changes were observed in treated male rats at 0.06 and 0.16 mg/L as compared to control. Lesions were observed in the anterior-most segment of the nasal passages, statistically higher incidence of suppurative (acute) inflammation of the mucosa of the nasal passages, Chronic ulceration of the epithelium of the external nares was observed in 3 male and Minimal squamous metaplasia of the respiratory epithelium in the trachea of one male rat were observed at 0.51 mg/L as compared to control. In one rat slight inflammation of the nasal mucosa (most anterior regions) were observed at 0.16 mg/L as compared to control andno microscopic lesions were observed in treated male rats at0.06 mg/L as compared to control. Therefore, NOAEC was considered to be 0.51 mg/l when Fischer 344 (F-344) CDF®[F-344]/CrIBR male rats were treated with phosphorus (3+) tribromide by Nose only vapor inhalation for4 hrs /day for 5 days.

In the above similar study, Fischer 344 (F-344) CDF®[F-344]/CrIBR male and female rats were treated with phosphorus (3+) tribromide in the concentration of 0, 0.03, 0.1, 0.3 mg/L by Nose only vapor inhalation for 4 h/day, excluding weekends (a total of 20 exposures) for 28 days. No mortality, signs of toxic stress and change in body weight were observed in treated male rats at 0.03, 0.1, 0.3 mg/L as compared to control. Small increase in MCV, Monocytes and Eosinophils; and decrease in Platelets count in male and female rats at 0.3 mg/L and decrease in Platelets count in male and female rats at 0.03 an 0.1 mg/L as compared to control. Increases in Chloride, Calcium and decrease in ALT, TrigIycerides level at 0.3 mg/L, Increases in Chloride and TrigIycerides level were observed at 0.1 mg/L and decrease in TrigIycerides level were observed at 0.03 mg/L as compared to control. Additional statistically significant differences in mean values of serum chemistry or hematologic parameters were sporadic and were not considered biologically significant. In addition, No statistically significant effect on Absolute and relative Liver, Kidneys, Testes, Ovaries, Brain, Spleen, Adrenals, Lungs, Thymus and Heart weight and gross pathological changes were observed in treated rats as compared to control. Exudate or evidence of mild inflammation of the anterior nasal passages in 3 male and 1 female were observed at 0.3 mg/L but not statistically significant compared to the control group values. Therefore, NOAEC was considered to be 0.3 mg/l when Fischer 344 (F-344) CDF®[F-344]/CrIBR male and female rats were treated with phosphorus (3+) tribromide by Nose only vapor inhalation for 4 hrs /day for 28 days.

Thus, based on the above study on phosphorus (3+) tribromide, it can be concluded that NOAEC value is less than 0.51 mg/L, Thus, comparing this value with the criteria of CLP regulation, phosphorus (3+) tribromideacetate can be Not classified for reproductive toxicity.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above study on phosphorus (3+) tribromide, it can be concluded that NOAEC value is less than 0.51 mg/L, Thus, comparing this value with the criteria of CLP regulation, phosphorus (3+) tribromideacetate can be Not classified for reproductive toxicity.

Additional information