Registration Dossier

Administrative data

Description of key information

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance does not cause concern of acute toxicity. 

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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association
Qualifier:
according to
Guideline:
other: Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association
Deviations:
no
Principles of method if other than guideline:
Method: other
GLP compliance:
not specified
Test type:
fixed dose procedure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
other
Doses:
500 mg per kg of body weight
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Mortality:
no mortality
Body weight:
Sex Initial Final Change
M 203 g 292 g + 89 g
F 178 g 228 g + 50 g
Gross pathology:
Necropsy of all animals following sacrifice revealed at the end of the 14-day post-dose observation period, no gross pathological changes that could be attributed to administration were observed.

RS-Freetext:
All animals survived, showed no abnormal clinical signs and
gained weight.  Gross necropsy did not reveal any test
material-related pathological changes.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The oral administration to rats of 500 mg of Surfynol 104 per kg of body weight resulted in no mortality.
Accordingly, the submitted test material is not considered a toxic material orally, under the definition set forth by the
Manufacturing Chemist´s Association.
Executive summary:

The oral administration to rats of 500 mg of Surfynol 104 per kg of body weight resulted in no mortality.

Accordingly, the submitted test material is not considered a toxic material orally, under the definition set forth by the

Manufacturing Chemist´s Association.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
500 mg/kg bw
Quality of whole database:
Study has been done before the establishment of GLP, but is following the Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association. Klimisch score 2.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association
Principles of method if other than guideline:
5 male rats (average weight 176 grams) and 5 female rats (average weight 211 grams) were placed in a 306 liter chamber.  The Surfynol 104 was prepared as a 5% aqueous solution.  An air flow of five liters per minute was introduced into the chamber.  The test solution was aerosolized to provide a concentration of greater than 20 mg of mist per liter of chamber air over the one-hour period.  The test atmosphere was not analyzed.  The animals were observed daily for 14 days.
GLP compliance:
no
Test type:
other: Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Duration of exposure:
ca. 1 h
Concentrations:
20 mg of mist per liter
No. of animals per sex per dose:
5 male and
5 female
Control animals:
no

Ocular and nasal irritation as well as a reduction in spontaneous activity were noted in all animals at the end of the one-hour exposure period. These symptoms disappeared within three hours.

All rats survived the one-hour exposure and the 14 -day observation period (post exposure).

All animals maintained a normal appearance and gained weight over the observation period. No evidence of gross lesions was found in the animals autopsied. Body weight data are presented in the following summary:

Sex Initial Final Change

M 176 g 288 g + 112 g

F 211 g 239 g + 28 g

Material              Sex       Initial       Final       Change

Surfynol 104       M       176 g       288 g       + 112 g

- " -                    F       211 g       239 g       + 28 g

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the results of this study, it was concluded that the Surfynol 104 sample submitted was not a toxic substance by inhalation according to specifications for such substances set forth by the Manufacturing Chemist´s Association, Inc.:
" ... a toxic substance falls within the following category: "a substance that has a median lethal concentration (LC50) in air of more than ..... 2 milligrams per liter but not more than 20 milligrams per liter of mist ..... when administrered by continuous inhalation for one hour or less to albino rats weighing between 200 grams and 300 grams each ... "
Executive summary:

Ocular and nasal irritation as well as a reduction in spontaneous activity were noted in all animals at the end of the one-hour exposure period. These symptoms disappeared within three hours.

All rats survived the one-hour exposure and the 14 -day observation period (post exposure).

All animals maintained a normal appearance and gained weight over the observation period. No evidence of gross lesions was found in the animals autopsied.

Material              Sex       Initial       Final       Change

Surfynol 104       M       176 g       288 g       + 112 g

- " -                    F       211 g       239 g       + 28 g

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 000 mg/m³
Quality of whole database:
Study has been done before the establishment of GLP, but is following the Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association. Klimisch score 2.

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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement of GLP Compliance
Test type:
fixed dose procedure
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
propylene glycol
Duration of exposure:
24 hours
Doses:
Dose level: 2000 mg/kg body weight
Dose Volume: 10 ml/kg body weight
No. of animals per sex per dose:
5 males and
5 females
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no data on CL
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of ill health or behaioural changes were observed during study period.
Body weight:
Low body weight gain or body weight loss was noted in all animals over the first week of the study and improved weight gain over the second week.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities. Pelvic dilatation of the right kidney was noted in one males. Renal pelvic dilation is a common finding in animals of this age and strain and therefore considered not related to treatment.
Other findings:
Treated skin abnormalities:
Scales and scabs were observed on the treated skin area among two females between day 4 and 6.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The dermal LD50 value of Surfynol 104 in rats of either sex was established as exceeding 2000 mg/kg/ body weight.
Executive summary:

This study was entitle "Assessment of acute dermal toxicity with Surfynol 104 in the rat".

The purpose of this study was to assess the toxicity of Surfynol 104 when administered to rats asa a single dermal dose.

The study was carried out in accordance with OECD Guidline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/96 /EEC, Part B.3, "Acute Toxicity - Dermal". Surfynol 104 was adminestered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period.

No mortality and no clinical signs of ill health were observed during the study. Skin abnormalities on the treated area included scales and scabs in two females between days 4 and 6. Low body weight gain or body weight loss was noted in all animals over the first week of the study and improved body weight gain over the second week. Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities.

The dermal LD50 value of Surfynol 104 in rats of either sex was established as exceeding 2000 mg/kg/ body weight.

Based on these results and according to the EEC criteria for classification and labeling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC). Surfynol 104 cannot be classified and has no obligatory labeling reqiurement.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP compliant and is of high quality, Klimisch score = 1

Additional information

There is no data gap.

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance does not cause concern of acute toxicity.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
This study contains data which meets the criteria set forth in Regulation EC No. 440/2008 for filling REACH endpoints. The data is generated in a reliable laboratory using established protocols.

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance doese not cause concern of acute toxicity.