Registration Dossier

Administrative data

Description of key information

Study performed prior to implementation of official testing guidelines but similar to OECD TG 404. Trimethylolpropane is not irritating to the skin of rabbits when applied for 24 hours (Bayer AG 1979, BASF, 1958).
Study performed prior to implementation of official testing guidelines but similar to OECD TG 405. Trimethylolpropane is not irritating to the eyes of rabbits (Bayer AG 1979, BASF 1958).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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: scientifically acceptable and sufficiently documented
Principles of method if other than guideline:
2 animals, application inside rabbit ear, exposure period 24 h, dose 500 mg/animal, post exposure period 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
white New Zealand rabbits, weight 3 to 4 kg
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
other: the oposite ear served as control
Amount / concentration applied:
amount: 500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
2 rabbits, application of 500 mg/animal moistened with water, at the inside of one ear of each of the 2 rabbits ( the other ear served as control), and fixed with a plaster for the exposure period of 24 h, then the skin was washed with water and soap, postexposure period 7 days.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 h, 2 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 h, 2 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritant / corrosive response data:
According to the available data the substance is not irritating
Other effects:
no data

According to the available data the substance is not irritating.

Interpretation of results:
GHS criteria not met
Executive summary:

Application of 500 mg Trimethylolpropane/rabbit on the inner surface of one rabbit's ear of each of the 2 rabbits (the other one served as control) for 24 hours followed by a 7-day-observation period, does not result in irritational effects at any time point (Bayer AG 1979).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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: scientifically acceptable and sufficiently documented
Principles of method if other than guideline:
2 animals, dose 50 mg/animal into the conjunctival sac, post exposure period 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of each of the 2 rabbits
Amount / concentration applied:
amount: 50 mg
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 2 and 7 d
Score:
0
Reversibility:
other: score = 0 at any time point
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
2
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
3
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Other effects:
no data

No data

Interpretation of results:
GHS criteria not met
Executive summary:

A dose of 50 mg/animal was applied into the conjunctival sac of one eye of each of 2 rabbits, postexposure observation period 7 days. Trimethylolpropane is not irritating (Bayer AG 1979).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

--Application to the skin

Application of 500 mg Trimethylolpropan/rabbit on the inner surface of one rabbit's ear of each of the 2 rabbits (the other one served as control) for 24 hours followed by a 7-day-observation period, does not result in irritational effects at any time point (Bayer AG, 1979).

This result was already noted in a former skin irritation study performed in rabbits (BASF AG, 1958).

TMP is not to be classified as a skin irritant.

---Application into the conjunctival sac of the eye

A dose of 50 mg/animal was applied into the conjunctival sac of one eye of each of 2 rabbits, and the post exposure observation period was 7 days. Trimethylolpropane is not irritating (Bayer AG 1979). Application of melted trimethylolpropane into the conjunctival sac of one eye of each of the 2 rabbits followed by an observation period of 5 days did not result in irritating effects to the eye of rabbits (BASF 1958).

TMP is not to be classified as an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
key study is used

Justification for selection of eye irritation endpoint:
key study is used

Justification for classification or non-classification

Directive 67/548/EEC, Annex 1:

Trimethylolpropane is not classified as irritating to skin and eyes.

Directive 67/548/EEC, Annex 1 and Regulation (EC) No. 1272/2008:

Based on the available data no classification is required.