Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: The LD50 (rat) was > 5000 mg/kg bw (equivalent or similar to 16 CFR 1500.3).

Acute inhalation toxicity: No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x 10E-04 Pa at 25 °C and is used primarily as a component of lubricants by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.


Acute dermal toxicity: The LD50 (rabbit) was > 2000 mg/kg bw (equivalent or similar to 16 CFR 1500.4).


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:
10 September 1982 - 20 October 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
GLP-like (QA signature) with limited information on individual animals
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16 CFR 1500.3 Federal Hazardous Substances Act Regulations.
Deviations:
no
GLP compliance:
yes
Remarks:
GLP-like (QA signature)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Weight at study initiation: average weight between 200~300 g.
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed and maintained in accordance with the Animal Welfare Act 9 CFR Part Stainless steel with elevated wire mesh flooring; 3 - 5 rats/cage by sex
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-09- 10 To: 1982 -09-24
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED: No data. Volume seleted to deliver dose of 5000 mg/kg bw

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period.
Statistics:
No data available
Preliminary study:
Not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
other: The animals had ruffled fur after 3 hours. They appeared normal within 24 hours and throughout the remainder of the observation period.
Gross pathology:
No gross abnormalities were noted in all animals.

Table 1. Results

Dose Level (mg/kg)

5000

Sex

Male

Female

Average Body Weight (g)

Initial

243

218

7 d

298

248

14 d

344

243

Mortality (No. death/No. dosed)

0/5

0/5

Interpretation of results:
not classified
Conclusions:
The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 5000 mg/kg bodyweight
Executive summary:

Test Guidance

Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.

Method and Material

A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.

Results

There were no mortalities or signs of clinical toxicity.

Conclusion

The acute oral LD50 in male and female rats was determined to be > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 January 1984 - 21 February 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
GLP-like (QA signature) with limited details on individual animals
Justification for type of information:
Study performed prior to commencement of REACH.
Qualifier:
equivalent or similar to guideline
Guideline:
other: US 16 CFR 1500.4 Federal Hazardous Substances Act
Deviations:
no
GLP compliance:
yes
Remarks:
GLP-like (QA signature)
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
- Age at study initiation: No data available
- Weight at study initiation: 2.3-3.0 kg
- Fasting period before study:
- Housing: The animals were individually housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW publication No. 80-23)
- Water: tap water was available ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-75
- Humidity (%): 40-45
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: 1/26/84-2/9/84
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back, abraided and intact skin
- % coverage: approximately 10 % of total body surface area.
- Type of wrap if used: gauze patch covered with an impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing: excess material was removed by wiping but not washing.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: correct amount to give a dose of 2000 mg/kg bw (not specified in the report)
- Concentration (if solution): the test material was used undiluted as supplied
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable

VEHICLE
- Amount(s) applied: Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no.: Not applicable
- Purity: Not applicable
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed daily for deaths or overt signs of toxicity. Individual bodyweights were recorded prior to application of the test material and Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period.
Statistics:
No data available
Preliminary study:
Not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 0
Clinical signs:
other: There were no signs of systemic toxicity.
Gross pathology:
Male: No gross abnormalities were noted
Female: no formed fecal material and spongy kidneys were noted for the animal that exhibited a loss in bodyweight. No gross abnormalities were noted for the remaining four animals
Other findings:
- Other observations: dermal reactions

Male/female: mild to moderate erythema was observed after unwrapping at 24 hours. By 4 days all animals exhibited eschar which persisted through day 14 of the study.

Table 1: Summary of mortality and bodyweight data

 

Males

Females

Intact

Abraded

Abraded

Intact

Mortality after 14 days

0

0

0

0

Average

bodyweights (kg)

Initial

2.87

2.73

2.70

2.73

7thday

2.89

2.82

2.82

2.66

Final

2.92

3.01

2.86

3.05

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article, when administered as received to male and female New Zealand White rabbits, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight
Executive summary:

Test Guidance

Acute dermal toxicity was performed to a method described in US 16 CFR 1500.4 Federal Hazardous Substances Act

Method and Material

A single dose of 2 g/kg undiluted test material was applied to the shaved backs of ten New Zealand White rabbits (5 males and 5 females). The skin of five animals (2 males and 3 females) was abraded prior to dosing. The test material was covered with an occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The sites were also examined for evidence of primary irritation daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14. At the end of the observation period all animals were euthanized and subjected to gross necropsy.

Results

There were no deaths or clinical signs of toxicity during the study. A loss of bodyweight was noted for one female at 14 days, all other animals showed expected gains. Mild to moderate erythema was observed in all animals after the 24 hour exposure and by day 4 of the observation period all animals exhibited eschar which persisted through day 14 of the study. Gross pathological examination showed no formed fecal material and spongy kidneys in the female that lost weight. No abnormalities were noted in the other animals. .

Conclusion

The dermal LD50 of the test material in male and female rabbits has been determined to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations [Costello, 1982]. A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals. There were no mortalities or signs of clinical toxicity. The acute oral LD50 in male and female rats is > 5000 mg/kg bw.

Acute inhalation toxicity:

No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x10E-04 Pa at 25°C and is used primarily as a component of lubricants by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.

 

Acute dermal toxicity:

Dermal toxicity was investigated using a similar method to that given in 16 CFR 1500.4 of the Federal Hazardous Substances Act Regulations. A single dose of 2 g/kg undiluted test material was applied to the shaved backs of ten New Zealand White rabbits (5 males and 5 females). The skin of five animals (2 males and 3 females) was abraded prior to dosing. The test material was covered with an occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The sites were also examined for evidence of primary irritation daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14. At the end of the observation period all animals were euthanized and subjected to gross necropsy. There were no deaths or clinical signs of toxicity during the study. A loss of bodyweight was noted for one female at 14 days, all other animals showed expected gains. Mild to moderate erythema was observed in all animals after the 24 hour exposure and by day 4 of the observation period all animals exhibited eschar which persisted through day 14 of the study. Gross pathological examination showed no formed fecal material and spongy kidneys in the female that lost weight. No abnormalities were noted in the other animals. The dermal LD50 of the test material in male and female rabbits was determined to be > 2000 mg/kg bw.

 

Justification for classification or non-classification

No adverse effect was observed during investigation of acute toxicity via the oral or dermal routes in female rats and, based on determined vapour pressure of the substance, exposure via the inhalation route is not considered to be of significance to humans under general use conditions at ambient temperature. As such, classification in accordance with Regulation (EC) No 1272/2008 is not required.