6-chlorohexan-1-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 20, 2020 to Octo 06, 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

2017

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

1-Chloro-6-Hydroxyhexane

IUPAC Name:

1-Chloro-6-Hydroxyhexane

Constituent 2

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

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Sponsor, 191217
- Purity, including information on contaminants, isomers, etc.: 98.50 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
The Wistar Han rat was chosen as the animal model for this study as recognized by international guidelines as a recommended test system. The test method and number of were based on the test guidelines.
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: Young adult animals (approximately 11-12 weeks old)
were selected
- Weight at study initiation: 220 to 226 g.
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm) containing sterilized wooden fibers as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures
- Water (e.g. ad libitum): Municipal tap-water was freely available to each animal via water bottles.
-- Microbiological status when known: The feed was analyzed by the supplier for nutritional components and environmental contaminants. The feed was analyzed by the supplier for nutritional components and environmental contaminants
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 44 – 70
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: an area of approximately 5x7 cm on the back of the animals
was clipped.
- % coverage: The test item was applied in an area of approximately 10% of the total body
surface, i.e. approximately 18 cm² for females.
- Type of wrap if used: The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after application period, successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The dose volume for each animal was based on the body weight measurement prior to dosing. Dose volume (mL/kg body weight) was calculated as follows: Dose level (g/kg) / spec.gravity or density (g/mL) * purity correction factor.
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for general health/mortality and moribunditytwice daily, in the morning and at the end of the working day; Post-dose observations were performed at periodic intervals on the day of dosing (at least
three times) and once daily thereafter: Animals were weighed individually on Day 1 (pre-dose), 8 and 15.
- Necropsy of survivors performed: yes/no
- Other examinations performed: irritation. The skin reactions were assessed approximately 24, 48 and 72 hours after the removal of the dressing and test item. Adjacent areas of untreated skin ofeach animal served as controls.

Results and discussion

Preliminary study:

A range finding study was performed in order to select the dose causing no mortality or
significant toxicity to be used in the main study. One animal was dosed at 2000 mg/kg. Based on the results of the range finding study, two animals were dosed at 2000 mg/kg.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The body weight gain shown by the surviving animals during the observation period was within the range expected for rats used in this type of study.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals

Any other information on results incl. tables

All results presented in the tables of the report are calculated using values as per the raw data rounding procedure and may not be exactly reproduced from the individual data presented.
The dermal LD50 value of the test item was ranked within the following ranges: 0-50, 50-
200, 200-1000 or 1000-2000 mg/kg b.w. or as exceeding 2000 mg/kg b.w.
The results can be evaluated according to the Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) of the United Nations (including all amendments) and the
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16
December 2008 on classification, labelling and packaging of items and mixtures (including
all amendments).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of test item in Wistar Han rats was established to exceed 2000 mg/kg body weight.
Based on these results, the test item does not have to be classified and has no obligatory
labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Executive summary:

TThe objective of this study was to determine the potential toxicity of 6-chlorohexan-1-ol, when given by a single dermal dose.
The study was carried out based on the guideline described in:
• OECD No. 402 (2017) "Acute Dermal Toxicity".
Initially, 6-chlorohexan-1-ol was administered to a single female Wistar Han rat by a single dermal application at 2000 mg/kg body weight for 24 hours in a range finder study. Based on the results, the main study was performed by dosing two females at 2000 mg/kg. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred.
No clinical signs were noted in the animals. Furthermore, no irritation was noted for any of
the animals at any time point. The body weight gain shown by the surviving animals during the observation period was within the range expected for rats used in this type of study.
No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of 6-chlorohexan-1-ol in Wistar Han rats was established to exceed
2000 mg/kg body weight.
Based on these results, PU-2020-905 does not have to be classified and has no obligatory
labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).