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EC number: 615-244-9 | CAS number: 71035-05-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- In a preliminary acute range-finding study conducted as part of this study, single oral (gavage) doses of 700, 2,000, or 8,000 mg/kg DEG were shown to produce dose related changes in renal function, as measured by several urinalysis parameters
A single (gavage) dose of 200 mg/kg DEG produced no changes. - Duration of treatment / exposure:
- 90 DAYS
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 8 females
- Control animals:
- yes
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- mortality
- organ weights and organ / body weight ratios
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Conclusions:
- A single group of eight adult female Sprague-Dawley rats was exposed daily to 0 or 200 mg/kg body weight DEG in drinking water for 90 days. In a preliminary acute range-finding study
conducted as part of this study, single oral (gavage) doses of 700, 2,000, or 8,000 mg/kg DEG were shown to produce dose-related changes in renal function, as measured by several urinalysis parameters. A single (gavage) dose of 200 mg/kg DEG produced no changes. Oral (drinking water) exposure to 200 mg/kg/day DEG for 90 days resulted in no significant effects on body weight or relative kidney weight versus the control groups.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity and carcinogenicity studies of Boric Acid
- Author:
- NTP
- Year:
- 1 987
- Bibliographic source:
- NTP tr 324
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 10043-35-3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Technical grade boric acid
- Analytical purity: 99.7 %
- Stability under test conditions: Stable
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, MI, USA
- Age at study initiation: 7-8 weeks old
- Feed: Ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: In food given ad libitum
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 13 weeks for control and top dose group, 16 weeks for other dose groups
- Frequency of treatment:
- 5 days per week in diet
Doses / concentrationsopen allclose all
- Remarks:
- 0, 169 (47), 560 (98), 1120 (196), 2240 (392), 4480 (784) mg boric acid (mg B)/day females
- Remarks:
- 0, 194 (34), 405 (71), 811 (142), 1622 (284), 3246 (568) mg boric acid (mg B)/day males
- No. of animals per sex per dose:
- 10 males and 10 females were used in each group.
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice per day
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all dose groups; organs: brain, spinal cord (if neurologic signs), pituitary, thyroid, parathyroid, thymus, oesophagus, salivary glands, stomach, small and large intestines, liver, pancreas, kidneys, adrenals, spleen, heart, trachea, lungs, bronchi, gonads, uterus, mammary gland, prostate, urinary bladder, gall bladder, mandibular lymph nodes, skin, eyes (if abnormal),
gross lesions and tissue masses.
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Eight out of the ten males and six out of the ten females from the 20000 ppm group died and one of the ten males from the 10000 ppm group died before end of study. Symptoms included nervousness, haunched appearance, dehydration, foot lesions and scaly tails. Incidences of extra medullary heamatopoiesis of spleen observed of varying severity in all dose groups for both males and females and hyperkeratosis and/or acanthosis of the stomach observed at the highest dose only in both males and females. At doses > 5,000 ppm (142 mg B/kg bw for the male), degeneration or atrophy of the seminiferous tubules was observed.
BODY WEIGHT AND WEIGHT GAIN
The mean bodyweights in the 5000, 10000 and 20000 ppm groups were 10 %, 17 % and 23 % lower than controls in males, and 8 %, 10 % and 18 % lower in females.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
food consumption increased by about 40 % by the 12th week in the 3 lower dose groups. Because of excessive scattering at the two highest dose levels intakes were unreliable.
GROSS PATHOLOGY AND HISTOPATHOLOGY: Incidences of extra medullary heamatopoiesis of spleen observed of varying severity in all dose groups for both males and females and hyperkeratosis and/or acanthosis of the stomach observed at the highest
dose only in both males and females. At doses of 5,000 ppm (142 mg B/kg bw for the male) and above, degeneration or atrophy of the seminiferous tubules was observed.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- > 811 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Critical effect in males was testis atrophy at doses (> 142mg B/kg bw) per day. In females deaths were observed at 4480 mg boric acid/kg bw (784mg B/kg bw)per day
- Dose descriptor:
- NOAEL
- Effect level:
- 1 200 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- mortality
- other: testes degeneration and splen extramed hematopoiesis
- Dose descriptor:
- NOAEL
- Effect level:
- 34 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- mortality
- other: testes degeneration and splen extramed hematopoiesis
- Dose descriptor:
- NOAEL
- Effect level:
- 194 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- dermal irritation
- mortality
- other: testes degeneration and splen extramed hematopoiesis
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Results Mouse 90 day of repeated dose toxicity study
Parameter
|
Control |
1200 ppm |
2500 ppm |
5000 ppm |
10000 ppm |
20000 ppm |
||||||
ma |
f |
m |
fa |
ma |
fa |
ma |
fa |
ma |
fa |
m |
f |
|
number of animals examined |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
Mortality |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
8 |
6 |
clinical signs |
0 |
0 |
+/- |
+/- |
+/- |
+/- |
+ |
+ |
+ |
+ |
++ |
++ |
body weight gain (g) |
11.7 |
9.4 |
10.2 |
8.4 |
10.5 |
8.3 |
7.3 |
7.2 |
5.2 |
6.6 |
2.7 |
4.1 |
food consumption g/kg bw (wk 12) |
140 |
190 |
165 |
229 |
164 |
219 |
199 |
271 |
456* |
431* |
753* |
1138* |
testes degeneration |
0/10 |
|
0/10 |
|
0/10 |
|
2/10 |
|
8/10 |
|
8/10 |
|
spleen extramed. hematopoiesis |
1 |
0 |
3 |
2 |
5 |
4 |
5 |
6 |
10 |
10 |
1 |
2 |
*unreliable because of food scatter
Applicant's summary and conclusion
- Conclusions:
- Eight out of the ten males and six out of the ten females from the 20000 ppm group died and one of the ten males from the 10000 ppm group died before end of study. Symptoms included nervousness, haunched appearance, dehydration, foot lesions and scaly tails. Incidences of extra medullary heamatopoiesis of spleen observed of varying severity in all dose groups for both males and females and hyperkeratosis and/or acanthosis of the stomach observed at the highest dose only in both males and females. At doses > 5,000 ppm (142 mg B/kg bw for the male), degeneration or atrophy of the seminiferous tubules was observed
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