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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The registration substance is irritating to skin and not irritating to eyes.

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
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented; the test material contained the registration substance by ca. 40%.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test material contained the registration substance by ca. 40%. The other components are not considered to possess significant irritating potentials.
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
three rabbits
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential was investigated according to the OECD Guideline 404. The test material contained the registration substance by 40 %.
The outcome of the study corresponded to "irritating" for the test material according to DSD 67/548/EEC. Taking account that the corresponding acid is not an irritant toskin and no local effect was observed in the combined repeated dose and reproductive/developmental toxicity screening (OECD 422), the registraton substance is assessed to be of "irritating". Xi, R38 is assigned.
Executive summary:

The skin irritation potential was investigated according to the OECD Guideline 404. The test material contained the registration substance by 40 %.

The outcome of the study corresponds to "irritating" for the test material according to DSD 67/548/EEC, whereas further evidences were considered to be necessary due to applied dose concentration of 40%.

Further evidences included:

- The obtained potency is far from the borderline to "corrosive".

- The registration substance is salt of a weak acid. When dissolved in the biological fluid, an immediate dissociation is expected. The stable dissolved species are then sodim ion, triethanolammonium ion and acid form of the registration substance. The acid form of the registration substance is not skin irritating (data provided as supporting study) and no irritation can be assigned to sodium ion. Triethanolamine as well as triethanolammonium compounds (i.e. triethanolammonium chloride) are classified as "irritating" and not "corrosive".

- No local irritation effect was observed in the repeated dose toxicity study, in which the registration substance was given per gavage to the rats (endpoint study record provided in 7.5).

In conclusion, the assignment of "irritating" (R38 according to DSD 67/548/EEC) for the registration substance is justified.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented; the test material contained the registration substance by 40%.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
0.1 ml of the test substance was applied once to the conjuctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with flourescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37°C.
The eyes were examined 1, 24, 48 and 72 hours after applicaiton of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal leions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjuctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes of two animals after 72 hours, further examinations were carried out after 7 days.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The values for individual animals were 1.0, 2.7, and 2.3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.9
Max. score:
3
Reversibility:
fully reversible within: 3 days
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.
The outcome of the study corresponded to "not irritating" for the test material according to DSD 67/548/EEC. Taking account that the corresponding acid is not an irritant to eyes and no local effect was observed in the combined repeated dose and reproductive/developmental toxicity screening (OECD 422), the registraton substance is assessed to be of "not irritating".
No classification is warranted.
Executive summary:

The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.

The outcome of the study corresponds to "not irritating" for the test material according to DSD 67/548/EEC, whereas further evidences were considered to be necessary, because obtained scores for conjunctiva redness were near to the borderline to "irritating".

Further evidences included:

- the scores obtained for cornea, iris and chemosis were clearly indicative of "not irritating",

- the effects were fully reversible within the observation period of 7 days,

- the corresponding acid was investigated at higher concentration (> 80%) and was not irritating,

- no local effect was observed in the combined repeated dose and reproductive/developmental toxicity that were performed with the registration substance.

Taking account of the all aspects, the registration substance is assessed as "not irritating" to eyes. No classification is warranted.

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

Additional information

Assessment of the skin irritation potential of the registration substance

The outcome of the provided key study is that the test material was irritating according to the criteria of DSD 67/548/EEC, whereas the obtained grades were near to the borderline of not irritating and irritating.

With respect that the test material contained the registration substance only by 40%, it should be discussed whether the potency of "irritaing" obtained for the test material is applicable for the registration substance.

The remaining 60% of the test material comprises teak oil, oleyl alcohol, polypropylen and water. These substances are not likely to be significantly irritating based on the given chemical structures. The observed irritation effect of the test material seems to be attributable to the registration substance that was tested at concentration of 40%.

In fact, no data is availabe to perform an quantitative extrapolation for higher concentration. However, there are a few aspect to support to assign "irritating" for the registration substance.

- The obtained potency is far from the borderline to "corrosive".

- The registration substance is salt of a weak acid. When dissolved in the biological fluid, an immediate dissociation is expected. The stable dissolved species are then sodim ion, triethanolammonium ion and acid form of the registration substance. The acid form of the registration substance is not skin irritating (data provided as supporting study) and no irritation can be assigned to sodium ion. Triethanolamine as well as triethanolammonium compounds (i.e. triethanolammonium chloride) are classified as "irritating" and not "corrosive".

- No severe local irritation effect was observed in the repeated dose toxicity study, in which the registration substance was given per gavage to the rats (endpoint study record provided in 7.5).

- The registration substance is produced and used only in dissolved form by ca. 40%.

In conclusion, the assignment of "irritating" (R38 according to DSD 67/548/EEC) for the registration substance is justified.

Assessment of the eye irritation potential of the registration substance

The outcome of the provided key study is that the test material was "not irritating" according to the criteria of DSD 67/548/EEC for the test material.

With respect that the test material contained the registration substance only by 40%, it should be discussed whether the potency of "not irritaing" obtained for the test material is applicable for the registration substance, also because the scores obtained for conjuntivae was near to the borderline "irritating".

The remaining 60% of the test material comprises teak oil, oleyl alcohol, polypropylen, water and triethanolamine. Except for triethanolamine, these substances are not likely to be significantly irritating based on the given chemical structures. The observed irritation effect of the test material seems to be attributable to the registration substance at concentration of 40%.

In fact, no data is availabe to perform a quantitative extrapolation for higher concentration. However, there are a few aspect to support to assign "not irritating" for the registration substance.

- The obtained scores for cornea, iris and chemosis were far from the borderline to "irritating".

- The observed effects were fully reversible within observation period of 7 days.

- The registration substance is salt of a weak acid. When dissolved in the biological fluid, an immediate dissociation is expected. The stable dissolved species are then sodim ion, triethanolammonium ion and the acid form of the registration substance. The acid form of the registration substance, (Pentapropenyl succinimido)-caproic acid, is not eye irritating (data provided as supporting study) and no irritation can be assigned to sodium ion.

- The registration substance is produced and used only in dissolved form by ca. 40%.

In conclusion, the assignment of "not irritating" for the registration substance is justified.


Justification for selection of skin irritation / corrosion endpoint:
Guideline study; well-performed and well-documented.

Justification for selection of eye irritation endpoint:
Guideline study; well-performed and well-documented.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The registration substance at concentration of 40% was investigated for its irritation potential according to the OECD Guideline 404 and 405.

The results obtained were "irritating" to skin and "not irritating" to eye for the test material. Due to the given concentration of 40% in the test material, further evidences such as irritation potential of corresponding acid and degree of irritation effect in the oral repeated dose toxicity were taken into account. The registration substance is assessed as "irritating" to skin and "not irritating" to eye according to DSD 67/548/EEC.