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EC number: 246-045-1 | CAS number: 24157-81-1
- Life Cycle description
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- Endpoint summary
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Toxicological Summary
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Endpoint summary
Administrative data
Description of key information
Subchronic (90 -day) repeated dose toxicity (feeding study, similar OECD 408): NOAEL (rat, m) = 105 mg/kg bw/day; NOAEL (rat, f) = 121 mg/kg bw/day
Study performed with 2,6-diisopropylnaphthalene (CAS No. 24157-81-1)
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,6-DIPN, diisopropylnaphthalene
- Physical state: tan solid (flakes)
- Analytical purity: 98.6
- Lot/batch No.: DP681432
- further informations are on file with the sponsor (Platte Chemical Co., Greeley, CO, USA)
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- other: Sprague-Dawley [Crl:CD(SD)IGS BR]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc., Portage, MI, USA
- Age at study initiation: appr. 6 weeks
- Weight at study initiation: males 160 - 219 g, females 116 - 152 g
- Fasting period before study: no data
- Housing: individually housed in suspended, stainless-steel cages
- Diet: cerified rodent diet (#8728CM meal, Harlan Teklad) ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 12 Feb 1999 To: 25 May 1999 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): appr. weekly
- Mixing appropriate amounts with (Type of food): appropriate amounts of test substance were mixed with certified rodent diet (see above). In a first step part of the diet was ground with the test substance in a mortal bowl. This premix was thoroughly mixed with the remaining rodent diet.
- Storage temperature of food: room temperature - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity was verified for the lowest and highest concentration by taking samples from the top, middle, and bottom of the food mix. These samples were also used for analysis at different time points (periods from 7 days to 4 weeks) to establish the stability of the test substance in the food preparation mix.
- Duration of treatment / exposure:
- 92 days
- Frequency of treatment:
- continuous
- Dose / conc.:
- 750 other: mg/kg diet (nominal in diet)
- Dose / conc.:
- 1 500 other: mg/kg diet (nominal in diet)
- Dose / conc.:
- 3 000 other: mg/kg diet (nominal in diet)
- Dose / conc.:
- 54 mg/kg bw/day (nominal)
- Remarks:
- males
- Dose / conc.:
- 105 mg/kg bw/day (nominal)
- Remarks:
- males
- Dose / conc.:
- 208 mg/kg bw/day (nominal)
- Remarks:
- males
- Dose / conc.:
- 62 mg/kg bw/day (nominal)
- Remarks:
- females
- Dose / conc.:
- 121 mg/kg bw/day (nominal)
- Remarks:
- females
- Dose / conc.:
- 245 mg/kg bw/day (nominal)
- Remarks:
- females
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satelite groups - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes; in accordance with regulations
DETAILED CLINICAL OBSERVATIONS: Yes; in accordance with regulations
BODY WEIGHT: Yes; in accordance with regulations
OPHTHALMOSCOPIC EXAMINATION: Yes; in accordance with regulations
HAEMATOLOGY: Yes; in accordance with regulations
CLINICAL CHEMISTRY: Yes; in accordance with regulations
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during week 12
- Dose groups that were examined:
- Battery of functions tested: motor activity, sensory reactivity (elicited behaviors) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights were determined and a comprehensive set of organs/tissues was collected and preserved in 10% neutral-buffered formalin.
HISTOPATHOLOGY: Yes, tissues (as appropriate) from each animal in the control and high dose group were prepared and examined microscopically. Macroscopic lesions, adrenals, kidneys, and liver were also examined microscopically from each animal in the low- and mid-dose groups. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No treatment-related, adverse effects were observed for all test substance concentrations except pupil constriction at the mean and top dose. There were no test material-related effects noted during handling, open field observation, or on sensory reactivity assessment.
There were no mortalities; all animals survived the study period until the scheduled sacrifice.
BODY WEIGHT AND WEIGHT GAIN
Body weight of highest-dosed males and females was significantly reduced (final weights about 86 and 88 % of control, respectively), Interim minor body weight changes in lower dose groups was transient and did not represent any pattern. They are not considered to be toxicologically important. Decreases in mean body weight were correlated with decreases in mean food consumption (see below).
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption was statistically reduced for males given 3000 ppm throughout the study. For 3000 ppm females, food consumption was slightly lower than controls through week 6, then comparable with controls for the remainder of the study.
Compound intake, averaged over the total study period, was 53.9, 104.6, and 207,6 mg/kg bw/day for males and 61.8, 121.4, and 244.7 mg/kg bw/day for females (750, 1500, and 3000 ppm groups respectively).
HAEMATOLOGY
In the male 3000-ppm group, slight effect on blood coagulation: mildly higher prothrombin and activated partial thromboplastin time were observed. In the female 1500- and 3000-ppm groups, red blood cell count, Hb, and haematocrit was mildly lowered. Effects were not considered to be adverse and of biological relevance.
CLINICAL CHEMISTRY
In 3000-ppm groups (males and females), slightly higher cholesterol was noticed. This effects was not considered to be adverse and of biological relevance.
ORGAN WEIGHTS
Statistically significant, absolute and/or relative organ-weight increases (adrenals, kidney and liver) noted in all female treated groups, were unrelated to dosage, except for the highest dose. In males given 3000 ppm, significantly increased kidney and adrenal weights appeared to be test material-related.
GROSS PATHOLOGY
There were no gross findings that could be attributed to the administration of the test material.
HISTOPATHOLOGY: NON-NEOPLASTIC
Test material-related changes were noted in the liver, kidney, and adrenal gland in animals given 3000 ppm.
Liver findings: increased incidence and severity of centrilobular hepatocytic hypertrophy (both sexes).
Kidney findings: tubular epithelial regeneration, degeneration/necrosis of tubular epithelium and intratubular cellular debris indicated tubular nephrosis (most prominent in males)
Adrenal gland findings: incidence and severity of cortical cell hypertrophy was increased (both sexes). - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 105 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: body weight; food consumption; organ weights; histopathology
- Remarks on result:
- other: NOAEL corresponds to 1500 mg/kg diet
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 121 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: body weight; organ weights; histopathology
- Remarks on result:
- other: NOAEL corresponds to 1500 mg/kg diet
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 208 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: body weight; food consumption; organ weights; histopathology
- Remarks on result:
- other: LOAEL corresponds to 3000 mg/kg diet
- Dose descriptor:
- LOAEL
- Effect level:
- 245 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: body weight; organ weights; histopathology
- Remarks on result:
- other: LOAEL corresponds to 3000 mg/kg diet
- Critical effects observed:
- not specified
- Conclusions:
- In a 90-day repeated dose toxicity feeding study, NOAEL values of 105 and 121 mg/kg bw/day for male and female Sprague-Dawley rats, respectively, were determined.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 105 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Item 8.6,, of Regulation (EC) No. 1907/2006.
- Organ:
- kidney
- liver
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 subchronic repeated dose toxicity of 2,6-diisopropylnaphthalene (CAS No. 24157-81-1) was investigated in a 90-day dietary study similar to OECD guideline 408 and observing GLP provisions (Henwood, 1999). Groups of 10 Sprague-Dawley (Crl:CD(SD)IGS BR) rats per dose and sex were administered the test substance at doses of 750, 1500 and 3000 ppm. The doses corresponded to approx. 39-87, 74-163, and 153-300 mg/kg/day for males and approx. 52-92, 94-171, and 209-319 mg/kg/day for females. The administration period lasted 92 days. Food and water were provided ad libitum. Administration of the test substance led to higher prothrombin time and activated partial thromboplastin time for high-dose males, lower red blood cell count, hemoglobin, and hematocrit for females of the mid- and high-dose groups and higher cholesterol for males and females fed 3000 ppm. Since there were no correlated anatomic pathology findings, the small differences for these parameters were not considered adverse. Terminal body weights were significantly decreased in the males given 3000 ppm. Absolute and/or relative organ weight increases of potential test material relationship included adrenal, kidney, and liver in all females of treatment groups. In the males, significantly increased kidney and adrenal weights in animals of the high-dose group were considered test material-related. Increased incidence and severity of centrilobular hepatocytic hypertrophy was seen in both sexes fed with 3000 ppm. Kidney changes at 3000 ppm suggestive of tubular nephrosis include tubular epithelial regeneration, degeneration/necrosis of the tubular epithelium and intratubular cellular debris. The renal changes were most prominent in the males. Adrenal gland findings included increased incidence and severity of cortical cell hypertrophy in both sexes of high-dose animals. Test substance-related histomorphologic changes were not seen at the 750 or 1500 ppm levels. Based on the microscopic findings in high-dose animals, the no-observed-adverse-effect level (NOAEL) is 1500 ppm, corresponding to 105 and 121 mg/kg bw/day for males and females, respectively.
Justification for classification or non-classification
The available data on oral repeated dose toxicity of 2,6-diisopropylnaphthalene (CAS No. 24157-81-1) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are, therefore, conclusive but not sufficient for classification.
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