Registration Dossier

Administrative data

Description of key information

The test substance is not irritant to the rabbit skin.
The instillation of the test substance resulted in serious damage to the eyes. Effects may be simply due to a mechanical particle effect. However a chemical action of the substance can not be excluded.

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:
adverse effect observed (irritating)

Additional information

Skin irritation

In a valid OECD Guideline study (OECD 404, adopted 1981) six rabbits were dermally exposed to 0.5 g neopentyl glycol (grinded and moistened with paraffin oil) for 4 h. Patches were removed and skin washed with water. Erythema and edema scores were read 1, 24, 48 und 72 h after patch removal and after 6, 8, 10, and 14 days. The max. mean score for erythema was 0.66 24 h after patch removal and for edema 0.33 24 and 48 h after removal (Huels 1985). In conclusion, only slight irritant effects to the skin of rabbits were induced; the test substance is not irritant to the skin.

Similar results were reported by BASF AG (1982; comparable to OECD Guideline 404 with acceptable restrictions). No edema (score 0) and no erythema (score 0) was detected in any rabbit at any time point.

Eye irritation

In a study conducted according to OECD Guideline 405 (adopted 1981; Huels 1985) 3 male and 3 female rabbits received instillations of ca. 100 mg crystalline test substance into the left conjunctival sac, the right eye was untreated (control). Scoring according to the Guideline was performed 1, 24, 48, and 72 hours and 6, 8, 10, 13, 17 and 21 days after instillation. The first 72 h after instillation necrosis of nictitating and mucous membrane of the conjunctivae of all 6 rabbits were reported. At termination (day 21) irreversible damage in 2 out of 6 rabbits was obvious: opacity of the cornea (grading score 2, area involved score 2) accompanied by circumcorneal injection and iritis. Effects may be simply due to a mechanical particle effect. However a chemical action of the substance can not be excluded.

Conclusion: The instillation of the test substance resulted in serious damage to the eyes.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation

Data from two independent studies suggested that no classification and labelling according to EC Regulation No. 1272/2008 or  

EU Directive 67/548/EEC is required.

Eye irritation

Induces serious damage to the eyes. The criteria for classification of EU Directive 67/548/EEC and Regulation (EC) No. 1272/2008 are met.