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Diss Factsheets

Administrative data

Description of key information

Acute toxicity: oral

LD50 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Acute toxicity: dermal

Acute Dermal Toxicity: LD50 > 2000 mg/kg (male/female Wistar rats)

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:
31 January 2017 to 15 February 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Acute Oral Toxicity-Acute Toxic Class Method, OECD Guideline for Testing of Chemicals No 423, Adopted: 17th December 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
No further details specified in the study report.
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species: Wistar rats
Source: Dobrá Voda, Slovak Republic
Number and Sex of Animals: 6 females
Age at First Dose: 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health: Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning.
The average room temperature was maintained within the range of 22.1 ± 0.5° C, relative humidity within 54.0 ± 3.5 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
Diet: The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in the cages were marked by a line on the tail with an ink marker.
Justification for the Choice of Species: Normally females are used for testing OECD TG 423 because females are typically the more sensitive gender.
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.
Doses:
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose.
No. of animals per sex per dose:
One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose.
Control animals:
no
Details on study design:
Dose Administration
The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test article administration, food was withheld for further 3-4 hours.

Clinical Observation
Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight
Individual weights of animals were measured immediately prior to test item was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Necropsy
All test animals were subjected to gross necropsy and the results were recorded for each animal.
Statistics:
Not specified
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study.
Clinical signs:
During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction negative reactions.
Body weight:
The body weights of all animals increasing slightly during the study. Stagnation of body weight increases was observed in 2 animals (rat No 3 and No 5) and a slight increase in the body weight of the rest animals was observed during the first and second week follow up.
Gross pathology:
All animals were necropsied. During necropsy, no macroscopic findings were observed.

Administration Results

Sex

Dose

ID

Result

Sex

Dose

ID

Result

Female

2000 mg/kg

1

Alive

Female

2000 mg/kg

4

Alive

2

Alive

5

Alive

3

Alive

6

Alive

 

Clinical Observation

Observation

Time After Administration

Hour

Day

Immediately

0.5

1

2

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Skin and Hair

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Eyes

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Mucosa

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Respirator System

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Circulatory System

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

CNS

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Somatomotric Activity

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Tremor

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Spasms

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Salivation

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Diarrhoea

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Lethargy

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Sleep

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Coma

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Death

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

- No observed signs

 

Body Weight

Sex

Dose

ID

Body Weight (g)

Body Weight Difference (g)

Initial

Week 1

Week 2

Week 1 – Initial

Week 2 – Initial

Week 2 – Week 1

Female

2000 mg/kg

1

200

220

225

20

25

5

2

200

225

230

25

30

5

3

180

200

200

20

20

0

4

185

185

190

0

5

5

5

205

210

210

5

5

0

6

205

205

210

0

5

5

 

Necropsy Results

Sex

Dose

ID

Result

Sex

Dose

ID

Result

Female

2000 mg/kg

1

No finding

Female

2000 mg/kg

4

No finding

2

No finding

5

No finding

3

No finding

6

No finding

 

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Hatcol 3178 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Hatcol 3178 is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.
Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Hatcol 3178 when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item related mortality was not observed during 24 hours and therefore in a next steps 3 females were treated with the same dose. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period.

The LD50 of the test item Hatcol 3178 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Hatcol 3178 is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
The substance is a member of a group of pentaerythritol and a mixture of alkyl carboxylic acids which share similar characteristics across the group. Please see attached justification for read across.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CAS 70639-33-3
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CAS 11138-60-6
Conclusions:
The substance, CAS 68441-67-8, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. The substance is considered to be not acutely toxic in contact with skin for the defined endpoints on the basis of read across. This will be confirmed by appropriate study data as soon as this is available.
Executive summary:

The substance, CAS 68441-67-8, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. The substance is considered to be not acutely toxic in contact with skin for the defined endpoints on the basis of read across. This will be confirmed by appropriate study data as soon as this is available.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
30 September 2003 to 15 October 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with OECD, EU & US EPA test guidelines in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species: Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EC). Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 5 males and 5 females (females were nullparous and nonpregnant).
Age and body weight: Young adult animals (approx. 9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Earmark

Conditions: Animals were housed in a controlled environment. in which optimal conditions were considered to be approximately 15 air changes per hour. a temperature of 21.0 ± 3.0°C (actual range: 17.2 - 22.3°C), a relative humidity of 30-70% (actual range: 39 -78%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accommodation: Individually housed in labelled Macrolon cages (type II, height 15 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany).
Water: Free access to tap-water.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was dosed undiluted as delivered by the sponsor.
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
Method: Dermal application.
Clipping: One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
Application: The test substance was applied in an area of approx. 10% of the total body surface, Le. approx. 25 cm2 for males and 18 cm2 for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage". A piece of Micropore tape was additionally used for fixation of the bandages in females only.
Frequency: Single dosage, on day 1.
Dose level (volume): 2000 mg/kg (2.0 ml/kg) body weight. Dose volume calculated as follows: dose level: specific gravity.
Application period: 24 hours, after which dressings were removed and the skin cleaned of residual test substance using Water.
Duration of exposure:
24 hours
Doses:
Single dosage. Dose level (volume): 2000 mg/kg (2.0 ml/kg) body weight.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, concurrent no treatment
Details on study design:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy: At the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
Statistics:
Not specified in the study report.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Chromodacryorrhoea (nose), hunched posture and lethargy were noted among the animals.
The animals had recovered from the symptoms by day 3.
Erythema was seen in the treated skin-area of one animal on day 3.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormaliies were found at macroscopic post mortem examination of the animals.
Other findings:
No further findings specified in the study report.

CLINICAL SIGNS

TEST DAY

 

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

HOURS AFTER TREATMENT

MAX GRADE

0

2

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MALES 2000 MG/KG

ANIMAL 1

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 2

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 3

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

1

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 4

POSTURE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hunched posture

(1)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

1

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 5

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

FEMALES 2000 MG/KG

ANIMAL 1

BEHAVIOUR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lethargy

(3)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 7

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

1

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 8

NO CLINICAL SIGNS NOTED

 

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 9

SKIN/FUR/PLUMAGE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Erythema maculate (treated skin)

(4)

-

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

1

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 10

SECRETION/EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chromodacryorrhoea (Nose)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-= Sign not observed; .=Observation not performed; +=Animal dead

 

BODY WEIGHTS (GRAMS)

SEX/DOSE LEVEL

ANIMAL

DAY 1

DAY 8

DAY 15

MALES 2000 MG/KG

 

1

373

377

423

 

2

329

346

371

 

3

315

334

356

 

4

334

354

385

 

5

347

369

386

 

MEAN

340

356

384

 

ST.DEV.

22

17

25

 

N

5

5

5

FEMALES 2000 MG/KG

 

6

194

203

217

 

7

240

250

263

 

8

250

254

282

 

9

248

251

273

 

10

200

215

223

 

MEAN

226

235

252

 

ST. DEV.

27

24

30

 

N

5

5

5

 

MACROSCOPIC FINDINGS

ANIMAL ORGAN

FINDINGS

DAY OF DEATH

MALES 2000 MG/KG

1

No findings noted

Schedule necropsy Day 15 after treatment

2

No findings noted

Schedule necropsy Day 15 after treatment

3

No findings noted

Schedule necropsy Day 15 after treatment

4

No findings noted

Schedule necropsy Day 15 after treatment

5

No findings noted

Schedule necropsy Day 15 after treatment

FEMALES 2000 MG/KG

6

No findings noted

Schedule necropsy Day 15 after treatment

7

No findings noted

Schedule necropsy Day 15 after treatment

8

No findings noted

Schedule necropsy Day 15 after treatment

9

No findings noted

Schedule necropsy Day 15 after treatment

10

No findings noted

Schedule necropsy Day 15 after treatment

 

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of HATCOL 5236 in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

Assessment of acute dermal toxicity with HATCOL 5236 in the rat.

The study was carried out based on the guidelines described in: "Acute Toxicity-Dermal", OECD No.402 (1987); "Acute Dermal Toxicity, EC Commission Directive 92/69/EEC, Part B.3 (1992); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.1200 (1996), "Acute Dermal Toxicity" and JMAFF: Japanese Test Guidelines (2000).

HATCOL 5236 was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred.

Chromodacryorrhoea (nose), hunched posture and lethargy were noted among the animals.

The animals had recovered from the symptoms by day 3.

Erythema was seen in the treated skin-area of one animal on day 3.

The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

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

The dermal LD50 value of HATCOL 5236 in Wistar rats was established to exceed 2000 mg/kgbody weight.

Based on these results and according to the:

OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), HATCOL 5236 does not have to be classified for acute toxicity by the dermal route.

EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), HATCOL 5236 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Jun - 05 Jul 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restriction (no analytical purity reported)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc., Denver, Pennsylvania
- Age at study initiation: young adults (at least 8 weeks)
- Weight at study initiation: 2.4-3.1 kg (males), 2.5-2.7 kg (females)
- Housing: Individually, in suspended, stainless steel cages with wire mesh bottoms
- Diet: Lab Rabbit Diet HF, No 5326 and No 5326, ad libitum
- Water: ad libitum
- Acclimation period: males 58 d, females 60 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 12 cm x 14 cm, clipped area of the dorsal trunk surface
- % coverage: approx. 10% of body surface
- Type of wrap if used: gauze secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with distilled water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; dermal examination: 1, 24, 48 and 72 h after bandage removal and on day 8 and 15 for the males, and on day 8 for the females; observations of toxicologic signs: 1, 2 and 4 h after dosing and daily thereafter for 14 days; body weight were recorded on day 0, 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: food consumption was recorded daily for determination of any decrease
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observtion.
Body weight:
At study ending one male and all five females showed no gain in body weight whereas the four remaining males lost weight over the whole study period (about -0.1 kg).
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
None of the animal showed dermal irritation.
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K1-2

Additional information

Acute toxicity: oral

The purpose of the study was to evaluate the potential toxic effect of the test item Hatcol 3178 when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item related mortality was not observed during 24 hours and therefore in a next steps 3 females were treated with the same dose. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period.

The LD50 of the test item Hatcol 3178 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Acute toxicity: Dermal

Assessment of acute dermal toxicity with HATCOL 5236 in the rat.

HATCOL 5236 was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Chromodacryorrhoea (nose), hunched posture and lethargy were noted among the animals. The animals had recovered from the symptoms by day 3. Erythema was seen in the treated skin-area of one animal on day 3. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value of HATCOL 5236 in Wistar rats was established to exceed 2000 mg/kg/body weight.

The semiocclusive application of 2000 mg/kg bw for 24 h (according to OECD 402) did not cause any adverse effects in rats expect for an initial reduction of body weight gain implicating that CAS No. 11138-60-6 is not acute toxic if applied on skin (RA-S, CAS 11138-60-6, Key, Exxon, Blanset, 1997, acute dermal, rabbit, RL2).

Justification for classification or non-classification

Acute toxicity: oral

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Hatcol 3178 is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Acute toxicity: dermal

The substance, CAS 68441-67-8, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. The substance is considered to be not acutely toxic in contact with skin for the defined endpoints on the basis of read across. The LD50 based on the read across to the two analogous substance is therefore deemed to be 2000 mg/kg bw and in accordance with Regulation (EC) 1272/2008 is therefore not classified.