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Diss Factsheets

Administrative data

Description of key information

Short summary and overall relevance of the provided information on acute oral toxicity

A rat acute oral toxicity study has been conducted on 1,9 -Nonanediol under OECD 401.

In a rat acute oral toxicity study 5 male and 5 female Sprague-Dawley rats received as single oral dose (via gavage) of 1,9-Nonanediol suspended in 0.5% w/v methylcellulose at 1260, 2000, 3200, 4000 or 5200 mg/kg bw. Rats were observed for 14 days. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period.

Treatment related clinical signs included hunched post mortem abnormal gait, ataxia and lethargy in the majority of animals dose at all levels. Group mean body weight gains were not affected. Mortality was observed in males dosed at 2000 mg/kg bw and above an in females dosed at 3200 mg/kg bw and above. No abnormalities were recorded at necropsy.

 

Short summary and overall relevance of the provided information on acute inhalation toxicity

In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as exposure of humans via inhalation is not likely taking account the vapour pressure of the test article, 1,9 Nonanediol.

 

Short summary and overall relevance of the provided information on acute dermal toxicity

In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh is scientifically robust.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-10-11 to 1988-11-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Chemical name: 1,9-Nonanediol
- CAS no.: 3937-56-2
- Purity: 99.9%
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight at dosing: m: 107-154g; f: 108-137g
Source: Charles River Portage, USA
Acclimation period: 12 days
Diet: Labsure LAD 1, ad libitum. animals fasted overnight prior to dosing and ~4 h post dosing
Water: Municipal water, ad libitum
Housing: Housed 5 animals of the same sex/cage
Temperature: 22-24°C
Humidity: 56%
Air changes: 15 changes/h
Photoperiod: 12 hours light/dark
Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
1% methyl cellulose
Details on oral exposure:
Refer to Details on study design
Doses:
Preliminary study: 2500 mg/kg bw (2 animals/sex)
Main study: 1260, 2000, 3200, 4000, 5000 mg/kg bw (5 animals/sex)
No. of animals per sex per dose:
Refer to Doses
Control animals:
no
Details on study design:
Animals (5/sex) were fasted overnight prior to compound administration. Animals recieved 1,9-Nonanediol as a single dose administered by oral gavage in 1% MC (dose volume 20 mL/kg bw) at 1260, 2000, 3200, 4000 or 5000 mg/kg bw. Clinical signs and body weight were monitored for 14 days following dosing. Animals were then necropsied and examined macroscopically.
Statistics:
Probit analysis
Preliminary study:
The acute median lethal oral dose to male and female rats was >2500 mg/kg bw.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Based on:
test mat.
95% CL:
ca. 2 200 - ca. 4 800
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3 600 mg/kg bw
Based on:
test mat.
95% CL:
ca. 2 500 - ca. 6 000
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 400 mg/kg bw
Based on:
test mat.
95% CL:
ca. 2 600 - ca. 4 800
Mortality:
Preliminary toxicity test:
1 male and 1 female died within 2 h of dosing

Main study:
Mortality was observed in males at 2000, 3200 and 5000 mg/kg bw and females at 3200, 4000 and 5000 mg/kg bw (refer to table below)
Clinical signs:
other: Piloerection was observed in all rats within 5 minutes of dosing. This was accompanied by: - hunched posture, abnormal gait and lethargy in the majority of rats dosed at 1260, 2000, 3200 and 4000 mg/kg bw - decreased respiration and pallor of the extremit
Gross pathology:
No treatment related effects were observed.

Table 7.2/01-1
Doses, mortality/ animals treated

Dose

(mg/kg bw)

 Mortality ratio

males

Mortality ratio

females

Mortality ratio

Gender combined

Preliminary study

2500

1/2

1/2

2/4

Main study

1260

0/5

0/5

0/10

2000

4/5

0/5

5/10

3200

2/5

2/5

4/10

4000

0/5

2/4*

2/9*

5000

5/5

5/5

10/10

* single animal died due to intubation error, excluded from mortality assessment

 

Table 7.2/01-2
Main study group body weights

Parameter

Body weights (mg/kg bw)

Body weights (mg/kg bw)

1260

2000

3200

4000

5000

1260

2000

3200

4000

5000

Day 1

118

144

142

128

116

119

124

121

124

120

Day 8

187

239

226

206

-

163

174

162

169

-

Day 15

237

299

278

261

-

187

193

183

194

-

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw in males and females. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified
Executive summary:

In a rat acute oral toxicity study 5 male and 5 female Sprague-Dawley rats received as single oral dose (via gavage) of 1,9-Nonanediol suspended in 0.5% w/v methylcellulose at 1260, 2000, 3200, 4000 or 5200 mg/kg bw. Rats were observed for 14 days. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period.

 

Treatment related clinical signs included hunched post mortem abnormal gait, ataxia and lethargy in the majority of animals dose at all levels. Group mean body weight gains were not affected. Mortality was observed in males dosed at 2000 mg/kg bw and above an in females dosed at 3200 mg/kg bw and above. No abnormalities were recorded at necropsy.

 

The EU endpoint conclusion was that the rat acute oral LD50 was >2000 mg/kg bw in males and females. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 200 mg/kg bw
Quality of whole database:
2 (reliable with restrictions) guideline study without detailed documentation

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Clinical signs:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Study period:
n/a
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose for cross-reference:
data waiving: supporting information
Qualifier:
no guideline required
Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, it is scientifically rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh.
Executive summary:

In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, it is scientifically rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Comparison with the CLP criteria

Oral and dermal

The acute oral LD50 in the rat of 3200/3600 mg/kg bw for males/females exceeds the values for which classification for acute oral toxicity is required (i.e. > 2000 mg/kg bw). Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9 -Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified.

 

The test article, 1,9- Nonanediol does not met the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic toxicity was observed in in vivo studies with dermal exposure (skin irritation and skin sensitisation]).

 

In accordance with the ECHA Chapter R.7a guidance and the EC CARACAL meeting, a waiver is requested as 1,9-Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for the acute dermal toxicity endpoint is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh is scientifically robust.

 

Inhalation

In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as exposure of humans via inhalation is not likely taking account the vapour pressure of the test article, 1,9 Nonanediol.

 

Overall conclusion

In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity and acute inhalation toxicity endpoint (based on exposure) is scientifically robust endpoint as stated in the R.7a guidance for REACh and these endpoints are not classified.