Registration Dossier

Administrative data

Description of key information

With regard to skin irritation, a primary irritation index of 0.5 was determined for the key study. In the eye irritation study, no adverse effects were observed.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The key study (Sanders, 2012c) to evaluate the skin irritation potential of the " reaction products of alcohols, C14 - 18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12 -14,-tert-alkyl" to the skin of the New Zealand White rabbit was conducted according to OECD 404 and EU Method B.4. A single 4‑hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight erythema. Two treated skin sites appeared normal at the 48‑hour observation and one treated skin site appeared normal at the 72‑hour observation. The test item produced a primary irritation index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation

The key study (Sanders, 2012d) was performed to assess the irritancy potential of the test item (reaction products of alcohols, C14 - 18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12 -14,-tert-alkyl) to the eye of the New Zealand White rabbit. The method was designed to be compatible with OECD 405 and EU Method B.5. A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Two treated eyes appeared normal at the 48‑hour observation and the remaining treated eye appeared normal at the 72‑hour observation. The test item produced a maximum group mean score of 11.3 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Skin irritation

According to the classification criteria outlined in the section 3.2.2.2. (Guidance on the Application of CLP criteria, 2012), if the mean value of ≥ 2,3 - ≤ 4,0 was reached for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal, the classification as Skin Irritant is assigned. The highest mean value for erythema/eschar was 1.0 in three animals at 24 -h reading point. The mean values of 0.33, 0.67 and 0.33 for erythema were measured in animal 1, 2 and 3 at 24 -h, 48 -h and 72 -h, respectively. The scores for oedema formation were all 0.0 for three animals at all reading time points. Therefore, this substance does not meet criteria under EU CLP Regulation (EC) No. 1272/2008) for classification and labelling as a skin irritant.

Eye irritation

According to the classification criteria outlined in the section 3.3.2.2. (Guidance on the Application of CLP criteria, 2012), if a substance cause positive but reversible reactions such as corneal opacity (score ≥ 1), iritis (score ≥ 1), conjunctival redness(score ≥ 2) or conjunctival oedema (chemosis) (score ≥ 2) in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after application, the classification as Eye Irritant (Category 2) is assigned. The average irritation scores over 24, 48, and 72 hours for corneal opacity, iritis, redness, and oedema, are 0 in 3/3 rabbits, 0 in 3/3 rabbits, < 0.66 in 3/3 rabbits, and < 0.33 in 3/3 rabbits, respectively. Therefore, this material does not meet the criteria for classification for eye irritation according to EU CLP Regulation (EC) No. 1272/2008.