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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
1-Chloro-6-Hydroxyhexane
IUPAC Name:
1-Chloro-6-Hydroxyhexane
Constituent 2
Chemical structure
Reference substance name:
6-chlorohexan-1-ol
EC Number:
217-925-2
EC Name:
6-chlorohexan-1-ol
Cas Number:
2009-83-8
Molecular formula:
C6H13ClO
IUPAC Name:
6-chlorohexan-1-ol
Test material form:
liquid: viscous
Details on test material:
Sample ID APCI000640
Chemical Name 1-chloro-6-hydroxyhexane
Physical State liquid
CAS # 2009-83-8
EU # 217-925-2
Manufacturer Air Products and Chemicals, Inc.
Batch # / Lot # 141125-1
Specific details on test material used for the study:
Batch# 1776194

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were received from Charles River, Stone Ridge NY, on 10 Mar 2016. Following an acclimation period of at least five days, three male and three healthy, non-pregnant and nulliparous female Sprague
Dawley rats were assigned to treatment groups without conscious bias. The animals were born on 13 Jan 2016 and 20 Jan 2016. The pretest body weight range was
278 - 299 grams for males and 184 - 208 grams for females. The animals were identified by cage notation and indelible body marks, and housed in suspended wire
cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat
Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a
12-hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle to three female rats and three male rats.
Doses:
Dose level of 2000 mg/kg was administered to three female rats and three male rats.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Type and Frequency of Observations
In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for
toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded
immediately pretest, weekly, at death and at termination in the survivors.
Post Mortem – Surviving animals were humanely sacrificed using CO2 and all animals were examined for
gross pathology following study termination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two female and three male rats survived following a single 2000 mg/kg oral dose. One female rat died on Day 1.
Clinical signs:
other: Prior to death, abnormal physical signs including dyspnea, wetness of the nose/mouth and anogenital area, ataxia, hunched posture, lethargy, flaccid muscle tone, cold to touch, and lacrimation were observed. Among the survivors, dyspnea, ataxia, flaccid m
Gross pathology:
The gross necropsy of the animal that died revealed wetness of the nose/mouth and anogenital area, red fluid in the bladder and abnormalities of the gastrointestinal tract. No observable
abnormalities were observed during the gross necropsy of the surviving animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The oral LD50 determined for 6-Chloro-1-hexanol by OECD 423 method is greater than 2000 mg/kg b.w.
Executive summary:

The oral LD50 determined for 6-Chloro-1-hexanol by OECD 423 method  is greater than 2000 mg/kg b.w.