Registration Dossier
Registration Dossier
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EC number: 257-288-8 | CAS number: 51566-62-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Route to route extrapolation:
No experimental data on absorption are available. Based on its physicochemical properties 3,7-dimethyloct-6-enenitrile is considered to become readily bioavailable via the dermal and oral route. On the basis of the low vapour pressure, the exposure of 3,7-dimethyloct-6-enenitrile via inalation as a vapour is low. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information to include a default factor of 2 in the case of oral-to-inhalation extrapolation. For dermal absorption, the default ratio of 1 for oral to dermal extrapolation is used for the DNEL derivation.
One study considered for DNEL derivation of 3,7-dimethyloct-6-enenitrile is a subchronic oral toxicity study (OECD 408) in rats (doses: 0, 10, 30, 100, 300 mg/kg bw/d; Safepharm Laboratories, 2008). At 300 mg/kg/bw/d, a statistically significant increase in total protein levels were observed in females and a statistically significant increase in albumin levels were observed in males. A statistically significant increase in abs./rel. liver weights was observed in both sexes treated with 300 mg/kg/day (>10% higher vs. respective controls). Abs./rel. liver weights were also significantly increased in males treated with 100 mg/kg/day (<10% higher vs. respective controls). Marginal centrilobular hepatocyte enlargement in both sexes at 300 mg/kg/day was observed. Two cases of centrilobular hepatocyte enlargement in males and one in females was found at 100 mg/kg/day. Based on these observations, the NOEL was determined to be 30 mg/kg/day and the NOAEL 300 mg/kg/day.
In an Extended One-Generation Reproduction Toxicity Study according to OECD guideline 443 (BASF SE, 2021),3,7-dimethyloct-6-enenitrilewas administered by gavage to groups of 25 male and 25 female Wistar rats at dose levels of 0 (test group 00), 25 (test group 01), 100 (test group 02) and 400 mg/kg body weight/day (mg/kg bw/d; test group 03). Corn oil served as vehicle. F0 animals were treated at least for 10 weeks prior to mating to produce litter (F1 generation). Pups of the F1 litter were selected (F1 rearing animals) and assigned to 2 different cohorts (1A and 1B) which were subjected to specific postweaning examinations. The study was terminated with the terminal sacrifice of the F1 rearing animals of cohort 1A. Control animals were dosed daily with the vehicle only (corn oil).Thus, under the conditions of this study, the NOAEL for general, systemic toxicity in the F0 animals is the mid-dose level of 100 mg/kg bw/d in females and the high-dose level of 400 mg/kg bw/d in males. In the F1A male offspring of high-dose group 13 (400 mg/kg bw/d), increased absolute reticulocyte counts in combination with increased spleen weights and higher grades of extramedullary hematopoiesis were signs of an increased red blood cell metabolism. F1A females showed no adverse signs of toxicity.Thus, under the conditions of this study, the NOAEL for general, systemic toxicity in the F1 animals is the mid-dose level of 100 mg/kg bw/d in males and the high-dose level of 400 mg/kg bw/d in females.The NOAEL for fertility and reproductive performance for the parental rats is 400 mg/kg bw/d, the highest tested dose.The NOAEL for developmental toxicity in the F1 progeny is 400 mg/kg bw/d, the highest tested dose
Another study considered for DNEL derivation of 3,7-dimethyloct-6-enenitrile is an one-generation reproduction study (OECD 415) in rats (doses: 0, 75, 200, 500 mg/kg bw/d; Charles River, 2011). Clinical signs in male rats included statistically significant increases in slight, moderate and extreme excess salivation and a low incidence of ungroomed coat at 500 mg/kg/day. Body weight gains for male rats were transiently, but significantly reduced during several time periods at 500 mg/kg/day, leading to terminal body weights reduced by 6% compared to controls. Statistically significant increases in absolute and relative weights of the brain, liver, kidneys and spleen occurred in rats treated with 500 mg/kg/day, without microscopic changes that could be correlated. Number of female rats with excess salivation was significantly increased at 500 mg/kg/day. Terminal body weights were significantly increased (by 5% compared to control) at 500 mg/kg/day. Significant increases in the absolute and relative weights of the liver and kidneys occurred at 500 mg/kg/day, without microscopic changes that could be correlated. In the ovaries, a slight increase in the mean number of follicles per animal was found at 500 mg/kg bw/day along with higher variability due to high numbers of primordial follicles in two rats only. Corpora lutea were present for all animals. The NOAEL for parental general systemic toxicity of 3,7-dimethyloct-6-enenitrile is 200 mg/kg bw/day. Since no reproductive effects and effects on the F1 generation was observed, the reproductive NOAEL in the P generation rats and the NOAEL for viability and growth of the F1 generation offspring is 500 mg/kg/day.
Developmental toxicity was evaluated in a study performed according to OECD Guideline 414 (BASF SE, 2016). Citronellylnitril was administered as a solution in corn oil to 25 "time-mated" female Wistar rats/group by stomach tube at doses of 50, 150 and 450 mg/kg bw on day 6 through day 19 post coitum (p.c.). As a result, the oral administration of Citronellylnitril to pregnant Wistar rats caused evidence of maternal toxicity at 450 mg/kg bw/d, namely increased liver weights (absolute +19% and relative +21%) and corresponding clinical-pathological changes (increased triglyceride and cholesterol values). No test substance-related adverse effects were observed in the fetuses at any dose group. In conclusion, the no observed adverse effect level (NOAEL) for maternal toxicity is 150 mg/kg bw/d.There were no toxicologically relevant adverse fetal findings evident. Thus, the no observed adverse effect level (NOAEL) for prenatal developmental toxicity is 450 mg/kg bw/d.
Under the conditions of a prenatal developmental toxicity study (BASF SE, 2021), the oral administration of Citronellylnitril to pregnant New Zealand White rabbits from implantation to one day prior to the expected day of parturition (GD 6-28) caused evidence of beginning maternal toxicity at a dose of 250 mg/kg bw/d, such as slightly but consistently food consumption and weight gain as well as mild anemia. In conclusion, the no observed adverse effect level (NOAEL) for maternal toxicity is 80 mg/kg bw/d. The no observed adverse effect level (NOAEL) for prenatal developmental toxicity is 250 mg/kg bw/d, the highest dose tested.
As the experimental exposure of a study according to Guideline OECD 414 adequately covered the pregnancy of the species under investigation an AF for exposure duration is not necessary.
Therefore the most conservative NOAEL, i.e. 200 mg/kg bw/day has been taken as point of departure for the respective DNELs. Since no adverse effects for reproductive toxicity have been observed, the respective NOAEL has not been taken into consideration for the DNEL derivation.
For the worker, the following DNELs were derived:
The NOAEL for parental general systemic toxicity derived from the one-generation reproduction study (OECD 415) was set at 200 mg/kg bw/day.
For derivation of the long-term systemic inhalative DNEL, the oral NOAEL was converted into a corrected inhalative NOAEC of 176.3 mg/m3 according to the procedure, recommended in the current guidance document (R8, ECHA 2012). Applying all assessment factors, the inhalative long-term systemic DNEL was set at 17.6 mg/m3 for the worker.
Long-term –inhalation, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 200 mg/kg bw/day |
|
Step 2) Modification of starting point |
2
0.38 m3/kg bw
6.7 m3/10 m3 |
Ratio of inhalation to oral absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance (R.8.4.2)
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3). |
Modified dose-descriptor |
NOAEC corrected inhalative = 200*(1/0.38)*(50/100)*(6.7/10) = 176.3 mg/m3 |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according to R8 ECHA 2012 |
Remaining differences |
1 |
On the basis of the general adverse systemic effects observed, i.e. body weight changes and liver effects resulting from hepatic enzyme induction / metabolic activation at high doses of 3,7-dimethyloct-6-enenitrile, no difference in sensitivity (toxicodynamic and/or additional toxicokinetic differences) between test animals and humans is to be expected besides aspects already covered in the route to route extrapolation performed above. |
Intraspecies |
5 |
Default assessment factor according to R8 ECHA 2012 |
Exposure duration |
2 |
Subchronic to chronic extrapolation |
Dose response |
1 |
according to R8 ECHA 2012 |
Quality of database |
1 |
based on validity of studies performed |
DNEL |
Value |
|
|
176.3 / (1 x 1 x 5 x 2 x 1 x 1) =17.6 mg/m3 |
|
For derivation of the long-term systemic dermal DNEL, the oral NOAEL was converted into a corrected dermal NOAEL of 200 mg/kg bw/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008).
Applying all assessment factors, the dermal long-term systemic DNEL derived was 5 mg/kg bw/d for the worker.
Long-term – dermal, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 200 mg/kg bw/day |
|
Step 2) Modification of starting point |
1 |
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral to dermal extrapolation. |
Modified dose-descriptor |
NOAEL corrected dermal = 200*(100/100) = 200 mg/kg bw/d |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
4 |
Assessment factor for allometric scaling according to R8 ECHA 2012 |
Remaining differences |
1 |
On the basis of the general adverse systemic effects observed, i.e. body weight changes and liver effects resulting from hepatic enzyme induction / metabolic activation at high doses of 3,7-dimethyloct-6-enenitrile, no difference in sensitivity (toxicodynamic and/or additional toxicokinetic differences) between test animals and humans is to be expected besides aspects already covered in the route to route extrapolation performed above. |
Intraspecies |
5 |
Default assessment factor according to R8 ECHA 2012 |
Exposure duration |
2 |
Subchronic to chronic extrapolation |
Dose response |
1 |
according to R8 ECHA 2012 |
Quality of database |
1 |
based on validity of studies performed |
DNEL |
Value |
|
|
200 / (4 x 1 x 5 x 2 x 1 x 1) =5 mg/kg bw/day |
|
No further DNELs were derived, since 3,7-dimethyloct-6-enenitrile does not pose any hazard, leading to a non-classification according to the criteria laid down under CLP.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Route to route extrapolation:
No experimental data on absorption are available. Based on its physicochemical properties 3,7-dimethyloct-6-enenitrile is considered to become readily bioavailable via the dermal and oral route. On the basis of the low vapour pressure, the exposure of 3,7-dimethyloct-6-enenitrile via inalation as a vapour is low. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information to include a default factor of 2 in the case of oral-to-inhalation extrapolation. For dermal absorption, the default ratio of 1 for oral to dermal extrapolation is used for the DNEL derivation.
One study considered for DNEL derivation of 3,7-dimethyloct-6-enenitrile is a subchronic oral toxicity study (OECD 408) in rats (doses: 0, 10, 30, 100, 300 mg/kg bw/d; Safepharm Laboratories, 2008). At 300 mg/kg/bw/d, a statistically significant increase in total protein levels were observed in females and a statistically significant increase in albumin levels were observed in males. A statistically significant increase in abs./rel. liver weights was observed in both sexes treated with 300 mg/kg/day (>10% higher vs. respective controls). Abs./rel. liver weights were also significantly increased in males treated with 100 mg/kg/day (<10% higher vs. respective controls). Marginal centrilobular hepatocyte enlargement in both sexes at 300 mg/kg/day was observed. Two cases of centrilobular hepatocyte enlargement in males and one in females was found at 100 mg/kg/day. Based on these observations, the NOEL was determined to be 30 mg/kg/day and the NOAEL 300 mg/kg/day.
In an Extended One-Generation Reproduction Toxicity Study according to OECD guideline 443 (BASF SE, 2021), 3,7-dimethyloct-6-enenitrile was administered by gavage to groups of 25 male and 25 female Wistar rats at dose levels of 0 (test group 00), 25 (test group 01), 100 (test group 02) and 400 mg/kg body weight/day (mg/kg bw/d; test group 03). Corn oil served as vehicle. F0 animals were treated at least for 10 weeks prior to mating to produce litter (F1 generation). Pups of the F1 litter were selected (F1 rearing animals) and assigned to 2 different cohorts (1A and 1B) which were subjected to specific postweaning examinations. The study was terminated with the terminal sacrifice of the F1 rearing animals of cohort 1A. Control animals were dosed daily with the vehicle only (corn oil).Thus, under the conditions of this study, the NOAEL for general, systemic toxicity in the F0 animals is the mid-dose level of 100 mg/kg bw/d in females and the high-dose level of 400 mg/kg bw/d in males. In the F1A male offspring of high-dose group 13 (400 mg/kg bw/d), increased absolute reticulocyte counts in combination with increased spleen weights and higher grades of extramedullary hematopoiesis were signs of an increased red blood cell metabolism. F1A females showed no adverse signs of toxicity.Thus, under the conditions of this study, the NOAEL for general, systemic toxicity in the F1 animals is the mid-dose level of 100 mg/kg bw/d in males and the high-dose level of 400 mg/kg bw/d in females.The NOAEL for fertility and reproductive performance for the parental rats is 400 mg/kg bw/d, the highest tested dose.The NOAEL for developmental toxicity in the F1 progeny is 400 mg/kg bw/d, the highest tested dose.
Another study considered for DNEL derivation of 3,7-dimethyloct-6-enenitrile is an one-generation reproduction study (OECD 415) in rats (doses: 0, 75, 200, 500 mg/kg bw/d; Charles River, 2011). Clinical signs in male rats included statistically significant increases in slight, moderate and extreme excess salivation and a low incidence of ungroomed coat at 500 mg/kg/day. Body weight gains for male rats were transiently, but significantly reduced during several time periods at 500 mg/kg/day, leading to terminal body weights reduced by 6% compared to controls. Statistically significant increases in absolute and relative weights of the brain, liver, kidneys and spleen occurred in rats treated with 500 mg/kg/day, without microscopic changes that could be correlated. Number of female rats with excess salivation was significantly increased at 500 mg/kg/day. Terminal body weights were significantly increased (by 5% compared to control) at 500 mg/kg/day. Significant increases in the absolute and relative weights of the liver and kidneys occurred at 500 mg/kg/day, without microscopic changes that could be correlated. In the ovaries, a slight increase in the mean number of follicles per animal was found at 500 mg/kg bw/day along with higher variability due to high numbers of primordial follicles in two rats only. Corpora lutea were present for all animals. The NOAEL for parental general systemic toxicity of 3,7-dimethyloct-6-enenitrile is 200 mg/kg bw/day. Since no reproductive effects and effects on the F1 generation was observed, the reproductive NOAEL in the P generation rats and the NOAEL for viability and growth of the F1 generation offspring is 500 mg/kg/day.
Developmental toxicity was evaluated in a study performed according to OECD Guideline 414 (BASF SE, 2016). Citronellylnitril was administered as a solution in corn oil to 25 "time-mated" female Wistar rats/group by stomach tube at doses of 50, 150 and 450 mg/kg bw on day 6 through day 19 post coitum (p.c.).As a result, the oral administration of Citronellylnitril to pregnant Wistar rats caused evidence of maternal toxicity at 450 mg/kg bw/d, namely increased liver weights (absolute +19% and relative +21%) and corresponding clinical-pathological changes (increased triglyceride and cholesterol values). No test substance-related adverse effects were observed in the fetuses at any dose group.In conclusion, the no observed adverse effect level (NOAEL) for maternal toxicity is 150 mg/kg bw/d.There were no toxicologically relevant adverse fetal findings evident. Thus, the no observed adverse effect level (NOAEL) for prenatal developmental toxicity is 450 mg/kg bw/d.
Under the conditions of a prenatal developmental toxicity study (BASF SE, 2021), the oral administration of Citronellylnitril to pregnant New Zealand White rabbits from implantation to one day prior to the expected day of parturition (GD 6-28) caused evidence of beginning maternal toxicity at a dose of 250 mg/kg bw/d, such as slightly but consistently food consumption and weight gain as well as mild anemia. In conclusion, the no observed adverse effect level (NOAEL) for maternal toxicity is 80 mg/kg bw/d. The no observed adverse effect level (NOAEL) for prenatal developmental toxicity is 250 mg/kg bw/d, the highest dose tested.
As the experimental exposure of a study according to Guideline OECD 414 adequately covered the pregnancy of the species under investigation an AF for exposure duration is not necessary.
Therefore the most conservative NOAEL, i.e. 200 mg/kg bw/day has been taken as point of departure for the respective DNELs. Since no adverse effects for reproductive toxicity have been observed, the respective NOAEL has not been taken into consideration for the DNEL derivation.
For the general population, the following DNELs were derived:
The NOAEL for parental general systemic toxicity derived from the one-generation reproduction study (OECD 415) was set at 200 mg/kg bw/day.
For derivation of the long-term systemic oral DNEL, the NOAEL for parental general systemic toxicity derived from the one-generation reproduction study (OECD 415) was used (200 mg/kg bw/day). After applying the assessment factors, the oral long-term systemic DNEL was set at 2.5 mg/ kg bw/day for the general population.
Long-term – oral, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 200 mg/kg bw/day |
|
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Allometric scaling |
4 |
Assessment factor for allometric scaling according to R8 ECHA 2012 |
Remaining differences |
1 |
On the basis of the general adverse systemic effects observed, i.e. body weight changes and liver effects resulting from hepatic enzyme induction / metabolic activation at high doses of 3,7-dimethyloct-6-enenitrile, no difference in sensitivity (toxicodynamic and/or additional toxicokinetic differences) between test animals and humans is to be expected besides aspects already covered in the route to route extrapolation performed above. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2012 |
Exposure duration |
2 |
Subchronic to chronic extrapolation |
Dose response |
1 |
according to R8 ECHA 2012 |
Quality of database |
1 |
based on validity of studies performed |
DNEL |
Value |
|
|
200 / (4 x 1 x 10 x 2 x 1 x 1) = 2.5 mg/kg bw/day |
|
For derivation of the long-term systemic inhalative DNEL, the oral NOAEL was converted into a corrected inhalative NOAEC of 87 mg/m3 according to the procedure, recommended in the current guidance document (R8, ECHA 2012). Applying all assessment factors, the inhalative long-term systemic DNEL was set at 4.35 mg/m3 for the general population.
Long-term – inhalation, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 200 mg/kg bw/day |
|
Step 2) Modification of starting point |
2
1.15 m3/kg bw
|
Proportion inhalation absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance (R.8.4.2)
|
Modified dose-descriptor |
NOAECinhalcorrected= 200*(1/1.15)*(50/100)= 87 mg/m3 |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according toR8 ECHA 2012 |
Remaining differences |
1 |
On the basis of the general adverse systemic effects observed, i.e. body weight changes and liver effects resulting from hepatic enzyme induction / metabolic activation at high doses of 3,7-dimethyloct-6-enenitrile, no difference in sensitivity (toxicodynamic and/or additional toxicokinetic differences) between test animals and humans is to be expected besides aspects already covered in the route to route extrapolation performed above. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2012 |
Exposure duration |
2 |
Subchronic to chronic extrapolation |
Dose response |
1 |
according to R8 ECHA 2012 |
Quality of database |
1 |
based on validity of studies performed |
DNEL |
Value |
|
|
87 / (1 x 1 x 10 x 2 x 1 x 1) = 4.35mg/m3 |
|
For derivation of the long-term systemic dermal DNEL, the oral NOAEL was converted into a corrected dermal NOAEL of 200 mg/kg bw/day according to the procedure, recommended in the current guidance document (R8, ECHA 2012). Applying all assessment factors, the dermal long-term systemic DNEL derived was 2.5 mg/kg bw/d for the general population.
Long-term – dermal, systemic effects
Description |
Value |
Remark |
Step 1) Relevantdose-descriptor |
NOAEL: 200 mg/kg bw/day |
|
Step 2) Modification of starting point |
1 |
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral to dermal extrapolation. |
Modified dose-descriptor |
NOAELcorrected dermal= 200*(100/100) = 200 mg/kg bw/d |
|
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Assessment factor for allometric scaling according to R8 ECHA 2012 |
Remaining differences |
1 |
On the basis of the general adverse systemic effects observed, i.e. body weight changes and liver effects resulting from hepatic enzyme induction / metabolic activation at high doses of 3,7-dimethyloct-6-enenitrile, no difference in sensitivity (toxicodynamic and/or additional toxicokinetic differences) between test animals and humans is to be expected besides aspects already covered in the route to route extrapolation performed above. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2012 |
Exposure duration |
2 |
Subchronic to chronic extrapolation |
Dose response |
1 |
according to R8 ECHA 2012 |
Quality of database |
1 |
based on validity of studies performed |
DNEL |
Value |
|
|
200 / (4 x 1 x 10 x 2 x 1 x 1) = 2.5 mg/kg bw/day |
|
No further DNELs were derived, since 3,7-dimethyloct-6-enenitrile does not pose any hazard, leading to a non-classification according to the criteria laid down under CLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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