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Administrative data

Description of key information

1-2(hydroxyethyl)-2-pyrrolidone was found to be not irritant the the skin and eye of rabbits.  
    

Irritation to the skin was investigated in a study performed according to a BASF internal method which is comparable to OECD guideline 404 (BASF AG, 1970). In this study Vienna White rabbits were exposed to 1-(2-hydroxyethyl)-2-pyrrolidone for 1, 5 or 15 minutes or 20 hours (n=2) under occlusive conditions to about 1 ml of the substance. No edema was observed under any of the test conditions. After 5 minutes exposure, in one animal erythema (score 1) was observed at 24 hours and after 15 minutes exposure, erythema (score 1) was observed in both animals after 24 hours. After 20 hours of exposure, erythema score 2 was reported at 24 hours for both animals. In all cases, the observed effects were fully reversible within 8 days. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.

In a second study, undiluted 1-2(hydroxyethyl)-2-pyrrolidone was tested for its skin irritation potential according to the method described in the Federal Register, Vol. 26, No. 155, p. 7336 12 Aug. 1961 (Fd. Drug Res. Labs. Inc., 1971). No signs of erythema or edema were observed after 24 and 72 hours (mean score 0).

 

Eye irritation

Eye irritation was investigated in a study performed according to a BASF internal method which is comparable to OECD guideline 405 (BASF AG, 1970). According to this method, 50 µL of the test substance was applied to the conjunctival sac of one eye of groups of 2 test animals. Findings were reported after 1 and 24 hours and an 8 -day observation period followed thereafter. Chemosis (score 2) was observed after 1 and 24 hours in animal 1 (fully reversible within: 4 days). In animal 1 a conjunctivae score of 2 was observed after 1 hour and a score of 1 was observed after 24 hours (fully reversible within: 4 days). In animal 2, a conjunctivae score of 1 was observed after 1 hour (fully reversible within: 24 hours). The findings in animal 1 disappeared completely after 4 days. In addition, fluorescein staining of the cornea was performed after 3 days (slight cloudiness after 3 days in one animal (also seen in the control eye) which disappeared after 4 days). Considering this information and the slight effects observed in the study, the substance is assessed to be non-irritant to the eyes according to regulatory criteria.

After a 20 hours occlusive exposure to the undiluted substance a erythema score 2 was reported for both animals. After 8 days, all findings had disappeared. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.

In a second study, undiluted 1-2(hydroxyethyl)-2-pyrrolidone was tested for its eye irritation potential according to the method described in the Federal Register, Vol. 29, No. 182, p. 13009, 17 Sept. 1964 (Fd Drug Res. Labs. Inc., 1971). The test material produced only a very slight conjunctival effect in (grade 1) in all of the animals which cleared by the second day of observation and is therefore tassessed to be non-irritant to the eyes of rabbits according to regulatory criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 404 was established, skin irritation was tested using an internal method (BASF test). Groups of two animals were treated for 1, 5, or 15 minutes or 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days).
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
other: intact skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
about 1 ml
Duration of treatment / exposure:
1, 5 and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2 per exposure duration
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin rinsed with Lutrol 50%
- Time after start of exposure: after treatment (1, 5 and 15 minutes and 20 hours)
Irritation parameter:
erythema score
Remarks:
(1 minute exposure)
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 1 minute exposure
Irritation parameter:
erythema score
Remarks:
(5 and 15 minutes exposure)
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 5 and 15 minutes exposure
Irritation parameter:
erythema score
Remarks:
(20 hours exposure)
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days. Already after 2 days, the erythema were very slight (score 1) in both animals.
Remarks on result:
other: 20 hours exposure
Irritation parameter:
edema score
Remarks:
(1, 5, 15 minutes and 20 hours exposure)
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 1, 5, 15 minutes and 20 hours exposure
Irritant / corrosive response data:
After a 20 hours occlusive exposure to the undiluted substance a erythema score 2 was reported for both animals. After 8 days, all findings had disappeared. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Fed. Reg., Vol 26, No. 155, p 7336, 12 Aug. 1961
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml, undiluted
Duration of treatment / exposure:
24 hours
Observation period:
24 hours (directly after exposure) and 72 hours (48 hours after first reading)
Number of animals:
6
Details on study design:
A minimum of 6 albino rabbits were used clipped free of hair. Only results for intact skin is reported below. 0.5 ml of the test substance were ntroduced under a square patch 1 inch x 1 inch , two single layers thick. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. After 24 hours of exposure the patches were removed and the reactions were evaluated . Readings were again made at the end of a 72 hours (48 hours after the first reading).
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no signs of erythema at any time point for all animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no signs of edeme at any time point for all animals

After a 24 and 72 hours of exposure to the undiluted substance no signs of erythema or edeme were reported (score in all animals 0). The substance is assessed to be non-irritant to the skin according to regulatory criteria.

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
according to Federal Register, Vol. 29, No. 182, p 13009, 17 Sept 1964
GLP compliance:
no
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, seves as a control. The eyes are not washed following instillation.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: iris was not affected in any animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: one day
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no conjuctival effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: one day
Remarks on result:
other: one animal affected grade 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no chemosis observed
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no discharge observed at any time point
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). 50 µL of the test substance was applied to the conjunctival sac of one eye in 2 animals. Findings were recorded daily. The eyes were not washed out after treatment as specified in OECD Guideline 405. Findings were recorded daily, the report describes findings after 1 and 24 hours and at the end of the 8-day observation period.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
1 hour, 24 hours and day 8 post-treatment
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour and 24 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 and 24 hours, 8 days
Score:
0
Max. score:
4
Irritant / corrosive response data:
According to the raw data, 24 hours after application of the undiluted substance, conjunctiva and chemosis (both score 2) were reported in one animal. The second animal was without any findings after 24 hours. The findings in animal 1 disappeared completely after 4 days. In addition, fluorescein staining of the cornea was performed after 3 days (slight cloudiness after 3 days in one animal (also seen in the control eye) which disappeared after 4 days). Considering this information and the slight effects observed in the study, the substance is assessed to be non-irritant to the eyes according to regulatory criteria.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Irritation to the skin was investigated in a study performed according to a BASF internal method which is comparable to OECD guideline 404 (BASF AG, 1970). In this study Vienna White rabbits were exposed to 1-(2-hydroxyethyl)-2-pyrrolidone for 1, 5 or 15 minutes or 20 hours (n=2) under occlusive conditions to about 1 ml of the substance. No edema was observed under any of the test conditions. After 5 minutes exposure, in one animal erythema (score 1) was observed at 24 hours and after 15 minutes exposure, erythema (score 1) was observed in both animals after 24 hours. After 20 hours of exposure, erythema score 2 was reported at 24 hours for both animals. In all cases, the observed effects were fully reversible within 8 days. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.

In a second study, undiluted 1-2(hydroxyethyl)-2-pyrrolidone was tested for its skin irritation potential according to the method described in the Federal Register, Vol. 26, No. 155, p. 7336 12 Aug. 1961 (Fd. Drug Res. Labs. Inc., 1971). No signs of erythema or edema were observed after 24 and 72 hours (mean score 0).

 

Eye irritation

Eye irritation was investigated in a study performed according to a BASF internal method which is comparable to OECD guideline 405 (BASF AG, 1970). According to this method, 50 µL of the test substance was applied to the conjunctival sac of one eye of groups of 2 test animals. Findings were reported after 1 and 24 hours and an 8 -day observation period followed thereafter. Chemosis (score 2) was observed after 1 and 24 hours in animal 1 (fully reversible within: 4 days). In animal 1 a conjunctivae score of 2 was observed after 1 hour and a score of 1 was observed after 24 hours (fully reversible within: 4 days). In animal 2, a conjunctivae score of 1 was observed after 1 hour (fully reversible within: 24 hours). The findings in animal 1 disappeared completely after 4 days. In addition, fluorescein staining of the cornea was performed after 3 days (slight cloudiness after 3 days in one animal (also seen in the control eye) which disappeared after 4 days). Considering this information and the slight effects observed in the study, the substance is assessed to be non-irritant to the eyes according to regulatory criteria.

After a 20 hours occlusive exposure to the undiluted substance a erythema score 2 was reported for both animals. After 8 days, all findings had disappeared. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.

In a second study, undiluted 1-2(hydroxyethyl)-2-pyrrolidone was tested for its eye irritation potential according to the method described in the Federal Register, Vol. 29, No. 182, p. 13009, 17 Sept. 1964 (Fd Drug Res. Labs. Inc., 1971). The test material produced only a very slight conjunctival effect in (grade 1) in all of the animals which cleared by the second day of observation and is therefore tassessed to be non-irritant to the eyes of rabbits according to regulatory criteria.

Justification for classification or non-classification

Based on the available data, the substance does need not to be classified for skin and eye irritation according to to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.