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EC number: 205-130-3 | CAS number: 134-11-2
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: via oral route;
No Observed Adverse Effect Level (NOAEL) is considered to be in a dose range of 735 -415 mg / kg body weight/day when male and female rats were orally treated with test chemical.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2-ethoxybenzoic acid (134-11-2) which is reported as 0.00211 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-ethoxybenzoic acid is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study;
The acute toxicity value for 2-ethoxybenzoic acid (134-11-2) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-ethoxybenzoic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-ethoxybenzoic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 735 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Weight of evidence prepared from various qulified publication.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The data available for the test chemical was reviewed to determine the toxic nature 2-ethoxybenzoic acid (134-11-2) repeated exposure by oral route. The study is as mentioned below:
Repeated dose toxicity: via oral route;
In a Chronic repeated dose toxicity study, Wistar male and female rats were treated with test chemical in the concentration of 0 and 415 mg/kg bw/day for male and 475 mg/kg bw/day for female. Animals were observed for body weight gain in intervals. Nostatistically significant effect was observed on Body weight gain of male and female rats as compared to control.Therefore, the No Observed adeverse effect level (NOAEL) was considered to be 415 mg/kg bw/day for male and 475 mg/kg bw/day for female when Wistar male and female rats were treated with test chemical.
Repeated oral toxicity study was performed to determine the toxic nature of test chemical. The study was performed using male and female F344 rats for 18-24 months. The test chemical was mixed with feed at dose levels of1 or 2% (approximately 370 or 735 mg/kg bw/d for males and 445 or 880 mg/kg bw/d for females, respectively). Groups of 50 male and 52 female Fischer 344 rats were used in the study. Control rats consisting of 25 males and 43 females received basal diet alone. Rats were group housed (5 rats/cage) and monitored for clinical signs, mortality, growth, food intake, and behavior. Body weight and food intake were recorded. An interim necropsy was conducted in the middle of the study on several rats randomly selected from each group. Necropsies also were conducted at study termination. During necropsy various organ tissues were prepared for microscopic examination. Mortality averaged 14.5% in all rat groups within the first 16 months of the study. All dead rats, with the exception of 1 female control rat, had pneumonia with abscess. After 16 months, 100 rats in total from all groups died of hemorrhagic pneumonia with edema. There were no reported differences in mortality, growth or food intake among treated and control rats. There also was no significant difference in benign (chromophobe adenoma of the pituitary, endometrial polyp, fibroadenoma of the mammary gland, and interstitial cell tumor of the testis) and malignant tumors (leukemia, malignant lymphoma, epidermoid carcinoma of the maxilla) in treated rats compared to controls. Based on the observations made, theNo Observed Adverse Effect Level (NOAEL) for test substance is considered to be735 mg/kg bw/d for males and 880 mg/kg bw/d for females, respectively.
Based on the data available from the test chemical 2-ethoxybenzoic acid (134-11-2) does not exhibit repeated dose oral toxicity in dose range 1000-735 mg/kg bw/day in rodent as well as in mammal. Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2-ethoxybenzoic acid (134-11-2) which is reported as 0.00211 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-ethoxybenzoic acid is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study;
The acute toxicity value for 2-ethoxybenzoic acid (134-11-2) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-ethoxybenzoic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-ethoxybenzoic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the test chemical 2-ethoxybenzoic acid (134-11-2) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the test chemical 2-ethoxybenzoic acid (134-11-2) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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