Registration Dossier

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.82 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

37.5

Modified dose descriptor starting point:

NOAEC

Value:

30.85 mg/m³

Explanation for the modification of the dose descriptor starting point:

Oral subacute repeated dose toxicity study available ( NOAEL 25 mg/kg; 28 day subacute gavage study).

Corrected human NOAEC = 30.85 mg/m³ (25 x 1/0,38 x7/5 x50/100 x 6.7/10)

A correction has to be made for workers because of their exposure only being 5 days a week instead of 7 days a week, which is a factor 7/5.

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route = 100% (default inhalation)

AF for dose response relationship:

1

Justification:

Default value ECHA

AF for differences in duration of exposure:

3

Justification:

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

AF for interspecies differences (allometric scaling):

1

Justification:

Default value ECHA

AF for other interspecies differences:

2.5

Justification:

Default value ECHA

AF for intraspecies differences:

5

Justification:

Default value ECHA

AF for the quality of the whole database:

1

Justification:

Default value ECHA

AF for remaining uncertainties:

1

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.64 mg/m³

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

skin irritation/corrosion

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

skin irritation/corrosion

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.23 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

150

Modified dose descriptor starting point:

NOAEL

Value:

35 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

A correction has to be made for workers because of their exposure only being 5 days a week instead of 7 days a week, which is a factor 7/5.

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route = 50% (default dermal)

25 x 7/5 = 35 [mg/kg bw]

AF for dose response relationship:

1

Justification:

Default value ECHA

AF for differences in duration of exposure:

3

Justification:

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

AF for interspecies differences (allometric scaling):

4

Justification:

Default value ECHA

AF for other interspecies differences:

2.5

Justification:

Default value ECHA

AF for intraspecies differences:

5

Justification:

Default value ECHA

AF for the quality of the whole database:

1

Justification:

Guideline study

AF for remaining uncertainties:

1

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

Route of original study:

Dermal

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Hazard assessment conclusion:

no hazard identified

Butanal, reaction products with aniline (CAS 68411-20-1)

DNELs (worker)

Repeated dose toxicity

A subacute gavage study in rats was evaluated for the derivation of DNELs of butanal, reaction products with aniline

Basis for delineation of the DNEL:

Study (rat study)

Repeated dose study

rat, male, female,

subacute gavage study for 28 days

rat: 0 (control), 25, 100, or 400 mg/kg/ day

Effects, NOAEL

NOAEL = 25 mg/kg bw (male + female rats)

Effects:

There was no mortality

Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg.

Histopathology showed significant changes in various organs at 100 mg/kg and/or 400 mg/kg:

- Spleen: Increased extramedullary hematopoiesis

- Liver: Hepatocellular hypertrophy

- Heart: Myocardial vacuolation

- Bone marrow (femur and sternum): Increase in cellularity

- Thyroid gland: Hypertrophy/hyperplasia of follicular cell epithelia

- Kidneys: Tubular swelling/degeneration

- Adrenals: Increased vacuolation of zona fasciculata cells

Reference

Popp L

Butanal, reaction products with aniline - Subacute oral toxicity study in Wistar rats (4-weeks administration by gavage)

Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

1.) Long-term tocixity – systemic effects (worker)

Long-term dermal route-systemic effects (worker) using default extrapolation factors:

NOAEL(rat, male) from a subacute toxicity study: 25 mg/kg bw/day

Penetration oral compared to dermal (both assumed 50%) 1

For interspecies rat vs. human: 4

For remaining interspecies differences: 2.5

For intraspecies differences in workers: 5

For extrapolation of exposure duration subacute to chronic: 3*

For reliability of dose-response: 1

For quality of whole database: 1

Overall factor: 150

Worker DNEL long-term for oral route-systemic: 0.23 mg/kg bw/day (35/ 150)

Oral subacute repeated dose toxicity study available ( NOAEL 25 mg/kg; 28 day subacute gavage study).

Corrected human NOAEC = 35 mg/kg (25 x 7/5)

A correction has to be made for workers because of their exposure only being 5 days a week instead of 7 days a week, which is a factor 7/5.

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

Worker DNEL long-term for dermal route-systemic: 0.23 mg/kg (35/ 150) mg/kg bw/day

Long-term inhalation route-systemic effects (worker):

NOAEL(rat) from a subacute oral toxicity study: 25 mg/kg bw/day

Correction of the starting point according TGD Figure R.8-3:

Corrected inhalatory NOAEC = Oral NOAEL (25 x 1/0,38 x7/5 x50/100 x 6.7/10)

=> NOAEC worker = 30.85 mg/m³

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route = 100% (default inhalation)

For interspecies differences rat vs. human: 1 (according TGD Table R.8-4. already covered by correction of starting point)

For remaining interspecies differences: 2.5

For intraspecies differences in workers: 5

For extrapolation of exposure duration subacute to chronic: 3*

For reliability of dose-response: 1

For quality of whole database: 1

Overall factor: 37.5

Worker DNEL long-term for inhalation exposure: 0.82 mg/m³ (30.85 / 37.5)

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

2.) Short-term toxicity – systemic effects (workers)

Dermal: Acute toxicity (dermal): Discriminating dose = 7940 mg/kg.

Inhalation: No acute study available. MAK: Exposure limit value of Anilin Factor 2 (peak expoure) compare to long-term exposure.

Worker DNEL short-term dermal route-systemic: No hazard identified (Discriminating dose = 7940 mg/kg)

Worker DNEL short-term for inhalation exposure: 0.29 mg/m³

Conclusion (systemic effects):

Worker DNEL long-term dermal route-systemic: 0.23 mg/kg bw/day

Worker DNEL long-term for inhalation exposure: 0.82 mg/m³

Worker DNEL short-term for dermal route-systemic: No hazard identified

Worker DNEL short-term for inhalation exposure: 1.64 mg/m³

3.) Reproductive Toxicity – systemic effects (worker)

Effects on reproductive organs in male and female rats were examined in a 4 week repeat dose toxicity study. Male and female reproductive organs and tissues were examined via gross necropsy as well as histopatholgical evaluations. Organ weight evaluations (absolute and relative) of several organs included an examination of testes, epidiymides, prostate, semical vesicle coagulation gland, ovaries, and uterus. No adverse effects on the reproductive organs examined were found.

As the NOAEL for fertility (400 mg/kg bw/day) is higher than the NOAEL for repeated dose toxicity (25 mg/kg bw/day), the derivation of a separate DNEL for fertility is not necessary, because the DNEL for repeated dose toxicity covers fertility.

No study is available for developmental toxicity / teratogenicity. A study is planned for conducting an OECD 421 screening study.

4. Irritation/corrosion to the skin and eyes

The test material was not irritating to the eyes and skin of rabbits, therefore a classification for skin and eye irritation is not justified.

5. Sensitization

In a LLNA , butanal, reaction products with aniline was a weak dermal sensitizer.

Butanal, reaction products with aniline is sensitizing and not irritating to the skin and eyes. Therefore a DNEL for local dermal effects is not applicable.

For local dermal effects butanal, reaction products with aniline should be allocated to the moderate hazard band.

For local inhalation effects butanal, reaction products with aniline no hazard identified ( Not classified for skin irritation).

Conclusion (systemic and local effects - worker):

Route of exposure DNEL; local effect DNEL; systemic effect

Dermal (long term) moderate hazard band 0.23 mg/kg/day

Dermal (short term) moderate hazard band No hazard identified

Inhalation (long term) No hazard identified 0.82 mg/m³/day

Inhalation (short term) No hazard identified 1.64 mg/m³

References:

• Popp L, Butanal, reaction products with aniline - Subacute oral toxicity study in Wistar rats (4-weeks administration by gavage), Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

• Mihail F, Vulkacit 576 - Untersuchung zur Haut- und Schleimhautvertraeglichkeit, Bayer - Institut fuer Toxikologie, Wuppertal-Elberfeld, Germany

• Leidenfrost P, Butanal, reaction products with aniline - Local lymph node assay in mice (LLNA/IMS), draft, Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.145 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

75

Dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

10.87 mg/m³

Explanation for the modification of the dose descriptor starting point:

Oral subacute repeated dose toxicity study available ( NOAEL 25 mg/kg; 28 day subacute gavage study).

Corrected human NOAEC = 10.87 mg/m³ (25 x 1/1,15 x 50/100)

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route = 100% (default inhalation)

AF for dose response relationship:

1

Justification:

Default value ECHA

AF for differences in duration of exposure:

3

Justification:

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

AF for interspecies differences (allometric scaling):

1

Justification:

Default value ECHA

AF for other interspecies differences:

2.5

Justification:

Default value ECHA

AF for intraspecies differences:

10

Justification:

Default value ECHA

AF for the quality of the whole database:

1

Justification:

Guideline study

AF for remaining uncertainties:

1

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.29 mg/m³

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

skin irritation/corrosion

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

skin irritation/corrosion

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.083 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

300

Dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

AF for dose response relationship:

1

Justification:

Default value ECHA

AF for differences in duration of exposure:

3

Justification:

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

AF for interspecies differences (allometric scaling):

4

Justification:

Default value ECHA

AF for other interspecies differences:

2.5

Justification:

Default value ECHA

AF for intraspecies differences:

10

Justification:

Default value ECHA

AF for the quality of the whole database:

1

Justification:

Guideline study.

AF for remaining uncertainties:

1

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

Route of original study:

Dermal

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.083 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

300

Dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

AF for dose response relationship:

1

Justification:

Default value ECHA

AF for differences in duration of exposure:

3

Justification:

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

AF for interspecies differences (allometric scaling):

4

Justification:

Default value ECHA

AF for other interspecies differences:

2.5

Justification:

Default value ECHA

AF for intraspecies differences:

10

Justification:

Default value ECHA

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

Route of original study:

Oral

Hazard assessment conclusion:

no hazard identified

Butanal, reaction products with aniline (CAS 68411-20-1)

DNELs (general population)

Repeated dose toxicity

A subacute gavage study in rats was evaluated for the derivation of DNELs of butanal, reaction products with aniline

Basis for delineation of the DNEL:

Study (rat study)

Repeated dose study

rat, male, female,

subacute gavage study for 28 days

rat: 0 (control), 25, 100, or 400 mg/kg/ day

Effects, NOAEL

NOAEL = 25 mg/kg bw (male + female rats)

Effects:

There was no mortality

Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg.

Histopathology showed significant changes in various organs at 100 mg/kg and/or 400 mg/kg:

- Spleen: Increased extramedullary hematopoiesis

- Liver: Hepatocellular hypertrophy

- Heart: Myocardial vacuolation

- Bone marrow (femur and sternum): Increase in cellularity

- Thyroid gland: Hypertrophy/hyperplasia of follicular cell epithelia

- Kidneys: Tubular swelling/degeneration

- Adrenals: Increased vacuolation of zona fasciculata cells

Reference

Popp L

Butanal, reaction products with aniline - Subacute oral toxicity study in Wistar rats (4-weeks administration by gavage)

Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

1.) Long-term tocixity – systemic effects (general population)

Long-term oral route-systemic effects (general population) using default extrapolation factors:

NOAEL(rat, male) from a subacute toxicity study: 25 mg/kg bw/day

Penetration oral compared to dermal (both assumed 50%) 1

For interspecies rat vs. human: 4

For remaining interspecies differences: 2.5

For intraspecies differences in general population: 10

For extrapolation of exposure duration subacute to chronic: 3*

For reliability of dose-response: 1

For quality of whole database: 1

Overall factor: 300

DNEL long-term for oral route-systemic: 0.083 mg/kg bw/day

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

DNEL long-term for oral and dermal route-systemic: 0.083 mg/kg bw/day

Long-term inhalation route-systemic effects (general population):

NOAEL(rat) from a subacute oral toxicity study: 25 mg/kg bw/day

Correction of the starting point according TGD Figure R.8-3:

Corrected inhalatory NOAEC = Oral NOAEL (25 x 1/1,15 x 50/100) mg/m³

=> NOAEC general population = 10.87 mg/m³

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route = 100% (default inhalation)

For interspecies differences rat vs. human: 1 (according TGD Table R.8-4. already covered by correction of starting point)

For remaining interspecies differences: 2.5

For intraspecies differences in general population: 10

For extrapolation of exposure duration subacute to chronic: 3*

For reliability of dose-response: 1

For quality of whole database: 1

Overall factor: 75

DNEL long-term for inhalation exposure: 0.145 mg/m³ (10.87 / 75)

*A reduced time extrapolation factors is considered appropriate for initial risk assessment because the main toxicological effects observed, hematology and spleen, are similar to effects observed with the main hydrolysis product aniline and these effects are considered to be acute effects independent of time of exposure (e.g. see DFG (Deutsche Forschungsgemeinschaft) (2010) MAK- und BAT-Werte-Liste 2010. Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Mitteilung 46, Wiley-VCH, Weinheim). Based on the limited data set for Butanal, reaction products with aniline a time extrapolation factor of 3 seems appropriate.

2.) Short-term toxicity – systemic effects (general population)

General population DNEL short-term for oral route-systemic: No hazard identified

General population DNEL short-term for dermal route-systemic: No hazard identified

General population DNEL short-term for inhalation exposure: 0.29 mg/m³

Conclusion (systemic effects):

General population DNEL long-term for oral route-systemic: 0.083 mg/kg bw/day

General population DNEL long-term for dermal route-systemic: 0.083 mg/kg bw/day

General population DNEL long-term for inhalation exposure: 0.145 mg/m³

General population DNEL short-term for oral route-systemic: No hazard identified

General population DNEL short-term for dermal route-systemic: No hazard identified

General population DNEL short-term for inhalation exposure: 0.29 mg/m³

3.) Reproductive Toxicity – systemic effects (general population)

Effects on reproductive organs in male and female rats were examined in a 4 week repeat dose toxicity study. Male and female reproductive organs and tissues were examined via gross necropsy as well as histopatholgical evaluations. Organ weight evaluations (absolute and relative) of several organs included an examination of testes, epidiymides, prostate, semical vesicle coagulation gland, ovaries, and uterus. No adverse effects on the reproductive organs examined were found.

As the NOAEL for fertility (400 mg/kg bw/day) is higher than the NOAEL for repeated dose toxicity (25 mg/kg bw/day), the derivation of a separate DNEL for fertility is not necessary, because the DNEL for repeated dose toxicity covers fertility.

No study is available for developmental toxicity / teratogenicity. A study is planned for conducting an OECD 421 screening study.

4. Irritation/corrosion to the skin and eyes

The test material was not irritating to the eyes and skin of rabbits, therefore a classification for skin and eye irritation is not justified.

5. Sensitization

In a LLNA , butanal, reaction products with aniline was a weak dermal sensitizer.

Butanal, reaction products with aniline is sensitizing and not irritating to the skin and eyes. Therefore a DNEL for local dermal effects is not applicable.

For local dermal effects butanal, reaction products with aniline should be allocated to the moderate hazard band.

For local inhalation effects butanal, reaction products with aniline no hazard identified ( Not classified for skin irritation).

Conclusion (systemic and local effects – general population):

Route of exposure DNEL; local effect DNEL; systemic effect

Oral (long term) not required 0.083 mg/kg/day

Oral (short term) not required No hazard identified ( LD50 > 3830 mg/kg bw)

Dermal (long term) moderate hazard band 0.083 mg/kg/day

Dermal (short term) moderate hazard band No hazard identified ( Discriminating dose = 7940 mg/kg)

Inhalation (long term) No hazard identified 0.145 mg/m³/day

Inhalation (short term) No hazard identified 0.29 mg/m³

References:

• Popp L, Butanal, reaction products with aniline - Subacute oral toxicity study in Wistar rats (4-weeks administration by gavage), Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

• Mihail F, Vulkacit 576 - Untersuchung zur Haut- und Schleimhautvertraeglichkeit, Bayer - Institut fuer Toxikologie, Wuppertal-Elberfeld, Germany

• Leidenfrost P, Butanal, reaction products with aniline - Local lymph node assay in mice (LLNA/IMS), draft, Bayer Pharma AG - Toxicology - 42096 Wuppertal, Germany

Registration Dossier

Registration Dossier

Data platform availability banner - registered substances factsheets

Diss Factsheets

Butanal, reaction products with aniline

Toxicological Summary

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

DNEL related information

Acute/short term exposure

DNEL related information

Local effects

Long term exposure

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

DNEL related information

Acute/short term exposure

DNEL related information

Local effects

Long term exposure

Acute/short term exposure

Workers - Hazard for the eyes

Local effects

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

DNEL related information

Acute/short term exposure

DNEL related information

Local effects

Long term exposure

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

DNEL related information

Acute/short term exposure

DNEL related information

Local effects

Long term exposure

Acute/short term exposure

General Population - Hazard via oral route

Systemic effects

Long term exposure

DNEL related information

Acute/short term exposure

DNEL related information

General Population - Hazard for the eyes

Local effects

Additional information - General Population